Systems and methods for assisting patient airway management

ABSTRACT

A medical system for assisting with an intubation procedure for a patient. The system comprising airflow sensors configured to obtain data indicative of airflow in the patient&#39;s airway and physiological sensors configured to obtain information regarding airflow in the patient&#39;s lungs. The system further including a monitoring device communicatively coupled to the airflow sensors and the physiological sensors. The patient monitoring device comprising at least one processor coupled to memory and configured to: provide a user interface on a display and assist the rescuer in determining proper placement of an endotracheal tube, receive the data indicative of the airflow in the patient&#39;s airway, receive the physiological information regarding the airflow in the patient&#39;s lungs, and determine whether the tube is properly placed based on the received physiological information, and present an output of the determination of whether the ET tube was properly placed.

RELATED APPLICATIONS

This application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application Ser. No. 62/618,391, filed on Jan. 17, 2018, theentire contents of which are hereby incorporated by reference.

BACKGROUND

A tracheal tube is a conduit that is inserted into the trachea of apatient to establish and maintain a patient's airway. Tracheal tubes arefrequently used for airway management in settings of general anesthesia,critical care and emergency medicine to provide mechanical ventilation.Tracheal tubes are used to ensure an adequate exchange of oxygen andcarbon dioxide, to deliver oxygen in higher concentrations than found inair, or to administer other gases to a patient.

An endotracheal tube is a specific type of tracheal tube that is usuallyinserted through the mouth or nose. It is a breathing channel designedto be placed into the airway of critically injured, ill, or anesthetizedsubjects in order to perform positive pressure ventilation of the lungsand to prevent the possibility of aspiration or airway obstruction.

Endotracheal intubation generally refers to the procedure for placing atracheal tube into the trachea of a patient to maintain an open airway,provide ventilatory assistance, or to serve as a conduit through whichto administer certain drugs. Intubation is generally performed incritically injured, ill or anesthetized subjects to facilitateventilation of the lungs and to prevent the possibility of asphyxiation,airway obstruction, or aspiration of gastric contents. To facilitateplacement of the endotracheal tube, rapid sequence intubation (RSI) is acommon method of prompt intubation of unconsciousness and neuromuscularblockage in emergency scenarios.

SUMMARY

An example of a medical system for assisting a rescuer with anintubation or other advanced airway procedure for a patient isdescribed. The system may include an airflow sensor configured to obtaindata indicative of airflow in the patient's airway, a physiologicalsensor configured to obtain information regarding airflow in thepatient's lungs, and a patient monitoring device communicatively coupledto the airflow sensor and the physiological sensor. The patientmonitoring device further includes at least one processor and memory.The at least one processor may be configured to receive the dataindicative of the airflow in the patient's airway, determine thepresence of airflow in the patient's airway based on the received data,initiate a timer based on the determined presence of airflow in thepatient's airway setting an interval to confirm proper placement of theET tube, receive the physiological information regarding the airflow inthe patient's lungs, determine whether ET tube is properly placed withinthe predetermined interval based on the received physiologicalinformation, and present to the user interface an output of thedetermination of whether the ET tube is properly placed.

Implementations of such a system may include one or of the followingfeatures. The medical system may include one or more airflow sensorsthat comprise at least one of: an oxygen sensor for measuring aconcentration of oxygen in the patient's airway, a flow sensor formeasuring gas flow rate in the patient's airway, and a capnographysensor for measuring a concentration of CO2 in the patient's airway. Themedical system may include one or more physiological sensors thatcomprises at least one of: pulse oximeter for obtaining oxygensaturation information from the patient, a capnography sensor forobtaining ETCO2 information from the patient, ECG sensors for obtainingECG signals from the patient, an acoustic sensor for obtaining acousticinformation from the patient, impedance sensors for obtaining atransthoracic impedance of the patient, and non-invasive blood pressuresensors for obtaining blood pressure of the patient.

The medical system may include one or more physiological sensors thatcomprise at least one of the capnography sensor, the impedance sensors,and the acoustic sensor. The medical system may include a patientmonitoring device that includes a defibrillator, the patient monitoringdevice comprises an automated external defibrillator or a professionalstyle defibrillator.

The medical system may further include user interface for assisting therescuer in determining proper placement of an endotracheal (ET) tube isconfigured to display visual feedback. The medical system may includevisual feedback that includes at least one of: oxygen saturation, endtidal CO2 (ETCO2), ECG signals from the patient, acoustic information, atransthoracic impedance, blood pressure, body temperature, heart rate,and respiration rate.

The medical system may include a display that is a touchscreen displayconfigured to receive input from the rescuer and wherein the patientmonitor includes more or more inputs for receiving information from therescuer. Additionally, the inputs include at least one of: softkeys,buttons, knobs, touchscreen inputs, and switches.

The medical system may further include one or more portable computingdevices communicatively coupled to the patient monitoring device totransmit and receive patient information from the patient monitoringdevice. The medical system may include one or more portable computingdevices that include at least one of a tablet computer, smartphone, andlaptop, wherein the portable computing device includes a touchscreendisplay for receiving patient information from the rescuer, the patientinformation including at least one of: a height, a weight, and a genderof the patient. The medical system may include a portable computingdevice that connects to one or more central facilities to obtainadditional patient information about the patient. The medical system mayinclude determination of whether the ET tube was properly placed priorto the expiration of the timer and is displayed on at least one of thedisplay of the patient monitoring device and the portable computingdevice.

The medical system may further provide physiological information fordetermining whether the ET tube is properly placed comprises an ETCO2value meeting a predetermined criterion. The medical system may providea predetermined criterion that comprises a measured ETCO2 valueexceeding a predetermined threshold. The medical system may provide apredetermined criterion that comprises a trend in measured ETCO2exceeding a predetermined threshold trend. The medical system mayprovide predetermined criterion that comprises a measured ETCO2 valuebeing greater or less than a percentage of a moving average of aplurality of previously measured ETCO2 values. The medical system mayprovide predetermined criterion that comprises consecutive measuredETCO2 value being greater or less than a percentage of a moving averageof a plurality of previously measured ETCO2 values.

The medical system may further provide physiological information fordetermining whether the ET tube is properly placed comprises atransthoracic impedance value meeting a predetermined criterion. Themedical system may provide predetermined criterion that comprises ameasured ETCO2 value exceeding a predetermined threshold.

The medical system may further provide predetermined criterion thatincludes a trend in measured ETCO2 exceeding a predetermined thresholdtrend. The medical system may provide at least one processor that isconfigured to initiate a timer based on the determined presence ofairflow in the patient's airway. Additionally, the at least oneprocessor may be configured to determine whether the ET tube is properlyplaced based prior to expiration of the timer. Additionally, the atleast one processor may be configured to present the output to the userinterface the determination of whether the ET tube was properly placedprior to the expiration of the timer. The medical system may furtherinclude a timer that is a default value between 5 and 15 seconds.Additionally, the medical system may further include a timer that is auser-defined value.

An example of a medical system for assisting a rescuer with anintubation procedure for a patient is described. The system may includeone or more airflow sensors configured to obtain data indicative ofairflow in the patient's airway; one or more physiological sensorsconfigured to obtain physiological information regarding airflow in thepatient's lungs; a patient monitoring device communicatively coupled tothe one or more airflow sensors and the one or more physiologicalsensors. The patient monitoring device may include a user interfacecomprising a display, and at least one processor and memory configuredto receive the data indicative of the airflow in the patient's airway,determine the presence of airflow in the patient's airway based on thereceived data, receive the physiological information regarding theairflow in the patient's lungs, determine a physiological baselineregarding airflow in the patient's lungs after placement of the ET tube,determine whether the ET tube remains properly placed based on adeviation from the physiological baseline, and present to the display ofthe user interface an output of the determination of whether the ET tuberemains properly placed.

Implementations of such a medical system may include one or more of thefollowing features. The physiological baseline may comprise an initialbaseline determined upon initial placement of the ET tube. The initialbaseline may include an average of a plurality of physiological valuesreceived upon initial placement of the ET tube. The deviation from thephysiological baseline may include a percentage difference between acurrent physiological value and the initial baseline. The physiologicalbaseline may include a dynamic baseline determined from updatedphysiological values obtained after initial tube placement. The dynamicbaseline may include a moving average of a plurality of physiologicalvalues received after placement of the ET tube. The medical system mayinclude one or more physiological sensors that includes at least one ofa capnography sensor, acoustic sensor, and an impedance sensor. Themedical system may include a one or more airflow sensors includes atleast one of an oxygen sensor for measuring a concentration of oxygen inthe patient's airway, a flow sensor for measuring gas flow rate in thepatient's airway, and a capnography sensor for measuring a concentrationof CO2 in the patient's airway.

The medical system may include one or more physiological sensorsincluding at least one of a capnography sensor for obtaining ETCO2information from the patient, an acoustic sensor for obtaining acousticinformation from the patient, and impedance sensors for obtaining atransthoracic impedance of the patient. The medical system may includeone or more physiological sensors including the capnography sensor andthe physiological baseline regarding the airflow in the patient's lungsincluding at least one ETCO2 value. The medical system may include atleast one ETCO2 value includes an initial baseline determined uponinitial placement of the ET tube. The medical system may include aninitial baseline that is determined as an average of a plurality ofETCO2 values upon initial placement of the ET tube. The medical systemmay provide a deviation from the physiological baseline that includes apercentage difference between at least one current ETCO2 value and theinitial baseline. The medical system may provide at least one ETCO2value includes a dynamic baseline with continually updated ETCO2 values.The medical system may provide a dynamic baseline that includes a movingaverage of a plurality of ETCO2 values received after placement of theET tube. The medical system may include one or more physiologicalsensors includes the transthoracic impedance sensor and thephysiological baseline regarding the airflow in the patient's lungsincludes at least one transthoracic impedance value. The medical systemmay provide at least one transthoracic impedance value that includes aninitial baseline determined upon initial placement of the ET tube.

The medical system may provide an initial baseline that includes anaverage of a plurality of initial transthoracic impedance valuesreceived upon initial placement of the ET tube. The medical system mayprovide a deviation from the physiological baseline includes apercentage difference between a current transthoracic impedance valueand the initial baseline. The medical system may provide at least onetransthoracic impedance value includes a dynamic baseline withcontinually updated transthoracic impedance values. The medical systemmay provide a dynamic baseline includes a moving average of a pluralityof transthoracic impedance values received after placement of the ETtube. The medical system may include one or more physiological sensorsthat includes the acoustic sensor and the physiological baselineregarding the airflow in the patient's lungs includes at least onespectral pattern. The medical system may provide at least one spectralpattern that includes an initial baseline determined upon initialplacement of the ET tube. The medical system may provide an initialbaseline that includes an average of a plurality of initial spectralcomponents received upon initial placement of the ET tube. The medicalsystem may provide a deviation from the physiological baseline thatincludes a percentage difference between a current spectral componentand the initial baseline.

The medical system may provide at least one spectral pattern thatincludes a dynamic baseline with continually updated spectral pattern.The medical system may provide a dynamic baseline includes a movingaverage of a plurality of spectral components received after placementof the ET tube. The medical system may include a patient monitoringdevice that includes a defibrillator. The medical system may include apatient monitoring device that includes an automated externaldefibrillator or a professional style defibrillator. The medical systemmay include a user interface that is configured to display visualfeedback. The medical system may provide a visual feedback that includesat least one of oxygen saturation, end tidal CO2 (ETCO2), ECG signalsfrom the patient, acoustic information, a transthoracic impedance, bloodpressure, body temperature, heart rate, and respiration rate. Themedical system may include a display that is a touchscreen displayconfigured to receive input from the rescuer. The medical system mayinclude a patient monitoring device includes one or more inputs forreceiving information from the rescuer. The medical system may includeinputs that include at least one of softkeys, buttons, knobs,touchscreen inputs, and switches. The medical system may include one ormore portable computing devices communicatively coupled to the patientmonitoring device to transmit and receive patient information from thepatient monitoring device.

The medical system may include one or more portable computing devicesincluding at least one of a tablet computer, smartphone, and laptop. Themedical system may include a portable computing device includes atouchscreen display for receiving patient information from the rescuer,the patient information including at least one of a height, a weight,and a gender of the patient. The medical system may include a portablecomputing device that connects to one or more central facilities toobtain additional patient information about the patient. The medicalsystem may provide a determination of whether the ET tube remainsproperly placed that is displayed on at least one of the display of thepatient monitoring device and the portable computing device. The medicalsystem may include at least one processor that is configured todetermine whether the ET tube remains properly placed prior toexpiration of the timer. The medical system may include at least oneprocessor that is configured to present the output of the determinationof whether the ET tube remains properly placed prior to the expirationof the timer. The medical system may provide a timer that is apredefined value between 5 and 15 seconds. The medical system mayprovide a timer that is a user-defined value. The medical system mayprovide a determination of whether the ET tube remains properly placedthat is based on a correlation between the received physiologicalinformation and the determined presence of airflow in the patient'sairway. The medical system may provide a correlation that includes aconfirmation that a positive pressure breath given to the patient hasreached the patient's lungs. The medical system may provide a positivepressure breath given to the patient that results in the determinedpresence of airflow in the patient's airway.

The medical system of claim may include at least one processor andmemory configured to determine a prior baseline before placement of theET tube is initiated, and determine whether the ET tube is properlyplaced based on a deviation from the prior baseline. The medical systemmay include one or more impedance sensors for obtaining a transthoracicimpedance of the patient, wherein the prior baseline is based on thetransthoracic impedance of the patient.

An example of a medical system for assisting a rescuer with anintubation procedure for a patient is described. The system may includeone or more airflow sensors configured to obtain data indicative ofairflow in the patient's airway, one or more capnography sensorsconfigured to obtain CO2 information regarding airflow in the patient'slungs, a patient monitoring device communicatively coupled to the one ormore airflow sensors and the one or more capnography sensors, thepatient monitoring device comprising a user interface comprising adisplay, and at least one processor and memory configured to receive thedata indicative of the airflow in the patient's airway, determine thepresence of airflow in the patient's airway based on the received data,receive the CO2 information regarding the airflow in the patient'slungs, determine whether the ET tube remains properly placed based onthe received CO2 information, and present to the display of the userinterface an output of the determination of whether the ET tube remainsproperly placed.

Implementations of such a medical system may include one or more of thefollowing features. The CO2 information for determining whether the ETtube remains properly placed may include an ETCO2 value meeting apredetermined criterion. The medical system may provide a predeterminedcriterion that includes a deviation from a physiological baselineregarding airflow in the patient's lungs. The medical system may includeat least one processor and memory that is configured to determine thephysiological baseline after initial placement of the ET tube. Themedical system may provide a physiological baseline that is an initialbaseline determined upon initial placement of the ET tube. The medicalsystem may include an initial baseline includes an average of aplurality of initial ETCO2 values received upon initial placement of theET tube. The medical system may provide a deviation from thephysiological baseline that includes a percentage difference between acurrent ETCO2 value and the initial baseline. The medical system mayprovide a physiological baseline that is a dynamic baseline withcontinually updated ETCO2 values measured after initial tube placement.The medical system may provide a dynamic baseline includes a movingaverage of a plurality of ETCO2 values received after placement of theET tube. The medical system may include a one or more airflow sensorsincludes at least one of an oxygen sensor for measuring a concentrationof oxygen in the patient's airway, and a flow sensor for measuring gasflow rate in the patient's airway.

The medical system may provide a predetermined criterion that includesan ETCO2 value exceeding a predetermined threshold. The medical systemmay provide a predetermined criterion includes an ETCO2 value fallingwithin a desired range. The medical system may provide an ETCO2 valuethat is determined as an average of a plurality of ETCO2 values, and thepredetermined criterion includes the average ETCO2 value exceeding thepredetermined threshold. The medical system may provide an ETCO2 valuethat is determined as an average of a plurality of ETCO2 values, and thepredetermined criterion includes the average ETCO2 value falling withinthe desired range. The medical system may provide a predeterminedcriterion includes a trend in the average ETCO2 value exceeding apredetermined threshold trend. The medical system may provide apredetermined criterion that includes an averaged ETCO2 value beinggreater a percentage of a moving average of a plurality of previouslymeasured ETCO2 values. The medical system may provide a predeterminedcriterion that includes an averaged ETCO2 value being less than apercentage of a moving average of a plurality of previously measuredETCO2 values. The medical system may include a patient monitoring deviceincludes a defibrillator. The medical system may include a patientmonitoring device includes an automated external defibrillator or aprofessional style defibrillator. The medical system may include a userinterface that is configured to display visual feedback.

The medical system may provide a visual feedback includes at least oneof oxygen saturation, end tidal CO2 (ETCO2), ECG signals from thepatient, acoustic information, a transthoracic impedance, bloodpressure, body temperature, heart rate, and respiration rate. Themedical system may include a display that is a touchscreen displayconfigured to receive input from the rescuer. The medical system mayinclude a patient monitoring device includes one or more inputs forreceiving information from the rescuer. The medical system may includeinputs include at least one of softkeys, buttons, knobs, touchscreeninputs, and switches. The medical system may include one or moreportable computing devices communicatively coupled to the patientmonitoring device to transmit and receive patient information from thepatient monitoring device. The medical system may include a one or moreportable computing devices includes at least one of a tablet computer,smartphone, and laptop. The medical system may include a portablecomputing device includes a touchscreen display for receiving patientinformation from the rescuer, the patient information including at leastone of a height, a weight, and a gender of the patient.

The medical system may include a portable computing device connects toone or more central facilities to obtain additional patient informationabout the patient. The medical system may provide a determination ofwhether the ET tube remains properly placed that is displayed on atleast one of the display of the patient monitoring device and theportable computing device. The medical system may include at least oneprocessor that is configured to initiate a timer based on the determinedpresence of airflow in the patient's airway. The medical system mayinclude at least one processor that is configured to determine whetherthe ET tube remains properly placed based prior to expiration of thetimer. The medical system may include at least one processor that isconfigured to present the output to the user interface the determinationof whether the ET tube remains properly placed prior to the expirationof the timer. The medical system may provide a timer that is apredefined value between 5 and 15 seconds. The medical system mayprovide a timer that is a user-defined value.

The medical system may provide a determination of whether the ET tuberemains properly placed that is based on a correlation between thereceived physiological information and the determined presence ofairflow in the patient's airway. The medical system may include acorrelation that includes a confirmation that a positive pressure breathgiven to the patient has reached the patient's lungs. The medical systemmay include a positive pressure breath given to the patient results inthe determined presence of airflow in the patient's airway. The medicalsystem may include one or more impedance sensors for obtaining atransthoracic impedance of the patient. The medical system may includeat least one processor and memory that is configured to receive thetransthoracic impedance regarding the airflow in the patient's lungs.The medical system may provide a determined physiological baselineincludes an initial transthoracic impedance baseline determined uponinitial placement of the ET tube.

The medical system may provide an initial transthoracic impedancebaseline that includes an average of a plurality of initialtransthoracic impedance values received upon initial placement of the ETtube. The medical system may provide a deviation from the physiologicalbaseline that includes a percentage difference between a currenttransthoracic impedance value and the initial baseline. The medicalsystem may provide a determined physiological baseline that includes adynamic transthoracic impedance baseline with continually updatedtransthoracic impedance values. The medical system may provide a dynamicbaseline that includes a moving average of a plurality of transthoracicimpedance values received after placement of the ET tube. The medicalsystem may include at least one processor and memory is configured todetermine a prior baseline before placement of the ET tube is initiated,and determine whether the ET tube is properly placed based on adeviation from the prior baseline. The medical system may include one ormore impedance sensors for obtaining a transthoracic impedance of thepatient, wherein the prior baseline is based on the transthoracicimpedance of the patient.

An example of a medical system for assisting a rescuer with anintubation procedure for a patient is described. The system may includeone or more airflow sensors configured to obtain data indicative ofairflow in the patient's airway, one or more impedance sensors forobtaining a transthoracic impedance of the patient, a patient monitoringdevice communicatively coupled to the one or more airflow sensors andthe one or more impedance sensors, the patient monitoring devicecomprising a user interface comprising a display, and at least oneprocessor and memory configured to receive the data indicative of theairflow in the patient's airway, determine the presence of airflow inthe patient's airway based on the received data, receive thetransthoracic impedance regarding the airflow in the patient's lungs,determine a physiological baseline regarding airflow in the patient'slungs after initial placement of the ET tube, determine whether the ETtube remains properly placed based on a deviation from the determinedphysiological baseline, and present to the display of the user interfacean output of the determination of whether the ET tube remains properlyplaced.

Implementations of such a medical system may include one or more of thefollowing features. The medical system may provide a physiologicalbaseline that is an initial baseline determined upon initial placementof the ET tube. The medical system may provide an initial baseline thatincludes an average of a plurality of initial transthoracic impedancevalues received upon initial placement of the ET tube. The medicalsystem may provide a deviation from the physiological baseline thatincludes a percentage difference between a current transthoracicimpedance value and the initial baseline. The medical system may providea physiological baseline that is a dynamic baseline with continuallyupdated transthoracic impedance values. The medical system may provide adynamic baseline that includes a moving average of a plurality oftransthoracic impedance values received after placement of the ET tube.

The medical system may include one or more airflow sensors that includeat least one of an oxygen sensor for measuring a concentration of oxygenin the patient's airway, a flow sensor for measuring gas flow rate inthe patient's airway, and a capnography sensor for measuring aconcentration of CO2 in the patient's airway. The medical system mayinclude a capnography sensor configured to obtain CO2 informationregarding airflow in the patient's lungs. The medical system may includeat least one processor and memory that is configured to receive the CO2information regarding the airflow in the patient's lungs. The medicalsystem may provide a determined physiological baseline that includes aninitial ETCO2 baseline determined upon initial placement of the ET tube.The medical system may provide an initial ETCO2 baseline that includesan average of a plurality of initial ETCO2 values received upon initialplacement of the ET tube. The medical system may provide a deviationfrom the physiological baseline that includes a percentage differencebetween a current ETCO2 value and the initial baseline.

The medical system may provide a determined physiological baseline thatincludes a dynamic ETCO2 baseline with continually updated transthoracicimpedance values. The medical system may provide a dynamic baseline thatincludes a moving average of a plurality of ETCO2 values received afterplacement of the ET tube.

The medical system may include a patient monitoring device includes adefibrillator. The medical system may include a patient monitoringdevice includes an automated external defibrillator or a professionalstyle defibrillator. The medical system may include a user interfacethat is configured to display visual feedback. The medical system mayprovide a visual feedback includes at least one of oxygen saturation,end tidal CO2 (ETCO2), ECG signals from the patient, acousticinformation, a transthoracic impedance, blood pressure, bodytemperature, heart rate, and respiration rate. The medical system mayinclude a display that is a touchscreen display configured to receiveinput from the rescuer. The medical system may include a patientmonitoring device includes one or more inputs for receiving informationfrom the rescuer. The medical system may include an inputs include atleast one of softkeys, buttons, knobs, touchscreen inputs, and switches.The medical system may include one or more portable computing devicescommunicatively coupled to the patient monitoring device to transmit andreceive patient information from the patient monitoring device. Themedical system may include a one or more portable computing devicesincludes at least one of a tablet computer, smartphone, and laptop. Themedical system may include a portable computing device includes atouchscreen display for receiving patient information from the rescuer,the patient information including at least one of a height, a weight,and a gender of the patient. The medical system may include a portablecomputing device connects to one or more central facilities to obtainadditional patient information about the patient.

The medical system may provide a determination of whether the ET tuberemains properly placed that is displayed on at least one of the displayof the patient monitoring device and the portable computing device. Themedical system may include at least one processor that is configured toinitiate a timer based on the determined presence of airflow in thepatient's airway. The medical system may include at least one processorthat is configured to determine whether the ET tube remains properlyplaced based prior to expiration of the timer. The medical system mayinclude at least one processor that is configured to present the outputto the user interface the determination of whether the ET tube remainsproperly placed prior to the expiration of the timer. The medical systemmay provide a timer that is a predefined value between 5 and 15 seconds.The medical system may provide a timer that is a user-defined value. Themedical system may provide a determination of whether the ET tuberemains properly placed that is based on a correlation between thereceived physiological information and the determined presence ofairflow in the patient's airway. The medical system may provide acorrelation that includes a confirmation that a positive pressure breathgiven to the patient has reached the patient's lungs. The medical systemmay provide a positive pressure breath given to the patient resulting inthe determined presence of airflow in the patient's airway.

The medical system may include at least one processor and memoryconfigured to determine a prior baseline before placement of the ET tubeis initiated, and determine whether the ET tube is properly placed basedon a deviation from the prior baseline. The prior baseline may be basedon the transthoracic impedance of the patient.

An example of a medical system for assisting a rescuer with anintubation procedure for a patient is described. The system may includeone or more airflow sensors configured to obtain data indicative ofairflow in the patient's airway, one or more acoustic sensors forobtaining acoustic information from the patient, a patient monitoringdevice communicatively coupled to the one or more airflow sensors andthe one or more acoustic sensors, the patient monitoring devicecomprising a user interface comprising a display, and at least oneprocessor and memory configured to receive the data indicative of theairflow in the patient's airway, determine the presence of airflow inthe patient's airway based on the received data, receive the acousticinformation regarding the airflow in the patient's lungs, determine aphysiological baseline regarding airflow in the patient's lungs afterinitial placement of the ET tube, determine whether the ET tube remainsproperly placed based on a deviation from the determined physiologicalbaseline, and present to the display of the user interface an output ofthe determination of whether the ET tube remains properly placed.

Implementations of such a medical system may include one or more of thefollowing features. The medical system may provide a physiologicalbaseline that is an initial baseline determined upon initial placementof the ET tube. The medical system may provide an initial baseline thatincludes an average of a plurality of initial spectral componentsreceived upon initial placement of the ET tube. The medical system mayprovide a deviation from the physiological baseline that includes apercentage difference between a current spectral pattern and the initialbaseline. The medical system may provide a physiological baseline thatis a dynamic baseline with continually updated spectral pattern. Themedical system may provide a dynamic baseline that includes a movingaverage of a plurality of spectral components received after placementof the ET tube. The medical system may include a one or more airflowsensors includes at least one of an oxygen sensor for measuring aconcentration of oxygen in the patient's airway, a flow sensor formeasuring gas flow rate in the patient's airway, and a capnographysensor for measuring a concentration of CO2 in the patient's airway. Themedical system may include a capnography sensor configured to obtain CO2information regarding airflow in the patient's lungs. The medical systemmay include at least one processor and memory that is configured toreceive the CO2 information regarding the airflow in the patient'slungs. The medical system may provide a determined physiologicalbaseline that includes an initial ETCO2 baseline determined upon initialplacement of the ET tube. The medical system may provide an initialETCO2 baseline that includes an average of a plurality of initial ETCO2values received upon initial placement of the ET tube. The medicalsystem may provide a deviation from the physiological baseline thatincludes a percentage difference between a current ETCO2 value and theinitial baseline.

The medical system may provide a determined physiological baseline thatincludes a dynamic ETCO2 baseline with continually updated transthoracicimpedance values. The medical system may provide a dynamic baseline thatincludes a moving average of a plurality of ETCO2 values received afterplacement of the ET tube. The medical system may include one or moreimpedance sensors for obtaining a transthoracic impedance of thepatient. The medical system may include at least one processor andmemory that is configured to receive the transthoracic impedanceregarding the airflow in the patient's lungs. The medical system mayprovide a determined physiological baseline that includes an initialtransthoracic impedance baseline determined upon initial placement ofthe ET tube. The medical system may provide an initial transthoracicimpedance baseline that includes an average of a plurality of initialtransthoracic impedance values received upon initial placement of the ETtube. The medical system may provide a deviation from the physiologicalbaseline that includes a percentage difference between a currenttransthoracic impedance value and the initial baseline. The medicalsystem may provide a determined physiological baseline that includes adynamic transthoracic impedance baseline with continually updatedtransthoracic impedance values. The medical system may provide a dynamicbaseline that includes a moving average of a plurality of transthoracicimpedance values received after placement of the ET tube.

The medical system may include a patient monitoring device that includesa defibrillator. The medical system may include a patient monitoringdevice includes an automated external defibrillator or a professionalstyle defibrillator. The medical system may include a user interfacethat is configured to display visual feedback. The medical system mayinclude a visual feedback includes at least one of oxygen saturation,end tidal CO2 (ETCO2), ECG signals from the patient, acousticinformation, a transthoracic impedance, blood pressure, bodytemperature, heart rate, and respiration rate. The medical system mayinclude a display that is a touchscreen display configured to receiveinput from the rescuer. The medical system may include a patientmonitoring device includes one or more inputs for receiving informationfrom the rescuer. The medical system may include an inputs include atleast one of softkeys, buttons, knobs, touchscreen inputs, and switches.The medical system may include one or more portable computing devicescommunicatively coupled to the patient monitoring device to transmit andreceive patient information from the patient monitoring device. Themedical system may include a one or more portable computing devicesincludes at least one of a tablet computer, smartphone, and laptop. Themedical system may include a portable computing device includes atouchscreen display for receiving patient information from the rescuer,the patient information including at least one of a height, a weight,and a gender of the patient.

The medical system may include a portable computing device that connectsto one or more central facilities to obtain additional patientinformation about the patient. The medical system may provide adetermination of whether the ET tube remains properly placed that isdisplayed on at least one of the display of the patient monitoringdevice and the portable computing device. The medical system may includeat least one processor that is configured to initiate a timer based onthe determined presence of airflow in the patient's airway. The medicalsystem may include at least one processor that is configured todetermine whether the ET tube remains properly placed based prior toexpiration of the timer. The medical system may include at least oneprocessor that is configured to present the output to the user interfacethe determination of whether the ET tube remains properly placed priorto the expiration of the timer. The medical system may provide a timerthat is a predefined value between 5 and 15 seconds. The medical systemmay provide a timer that is a user-defined value. The medical system mayprovide a determination of whether the ET tube remains properly placedthat is based on a correlation between the received physiologicalinformation and the determined presence of airflow in the patient'sairway. The medical system may provide a correlation that includes aconfirmation that a positive pressure breath given to the patient hasreached the patient's lungs. The medical system may provide a positivepressure breath given to the patient that results in the determinedpresence of airflow in the patient's airway.

The medical system may include at least one processor configured todetermine whether the ET tube remains properly placed based prior toexpiration of the timer. The medical system may an output to the userinterface of a determination of whether the ET tube remains properlyplaced prior to the expiration of the timer.

An example of a medical system for assisting a rescuer in performing oneor more steps of an airway intubation procedure on a patient isdescribed. The system may comprise one or more sensors configured toobtain one or more intubation parameters, and a medical devicecommunicatively coupled to the one or more sensors, the medical devicereceiving the one or more intubation parameters from the one or moresensors. The system may further comprise a processor of the medicaldevice configured to analyze the obtained intubation parameters from theone or more sensors and identify which step of the airway intubationprocedure is being performed on the patient based on values of the oneor more intubation parameters. The system includes an output device ofthe medical device configured to generate feedback based on which of theidentified one or more steps of the airway intubation procedure is beingperformed. Lastly, the processor detects when a different step of theone or more steps of the airway intubation procedure is performed basedon the values of the one or more intubation parameters changing, andadjusts the feedback of the output device to correspond to the detecteddifferent step being performed. Implementations of such a system mayinclude one or more of the following features.

An example of another for a medical system for assisting a rescuer witha rapid sequence intubation (RSI) procedure is provided. The medicalsystem may include one or more sensors configured to obtain dataindicative of one or more intubation parameters (e.g., gas parameter(s),physiological parameter(s), positioning parameter(s), and a patientmonitoring device communicatively coupled to the one or more sensors.The patient monitoring device may include a user interface, a memorycomprising a plurality of predetermined RSI steps and a plurality ofintubation parameter values corresponding to the plurality ofpredetermined RSI steps, a processor coupled to the memory. Theprocessor may be configured to receive data indicative of one or moreintubation parameters, estimate one or more intubation parameter valuesbased on the data, detect a transition from a first RSI step to a secondRSI step chosen from the plurality of predetermined RSI steps based on achange in the one or more intubation parameter values, and present tothe user interface an output to assist the rescuer in performing thesecond RSI step. In various embodiments, gas parameters may include oneor more of oxygen (O2) concentration, carbon dioxide (CO2)concentration, gas flow rate, inspiratory flow rate, expiratory flowrate, tidal volume, minute volume, airway pressure, gas temperature, andgas humidity. Physiological parameters may include one or more of oxygensaturation, end-tidal CO2, pulse oximetry, near infrared spectroscopy,transthoracic impedance, ECG, acoustic information, and blood pressure.Positioning parameters may include one or more of motion information,displacement, position information, velocity, acceleration, videoinformation, and image information. The medical system may comprise adefibrillator. The medical system may require the rescuers to verify thedetected different step manually prior to the output device adjustingthe feedback. The one or more sensors may comprise a pulse oximeterconfigured to acquire oxygen saturation information from the patient.The output device is configured to initiate an alarm if the oxygensaturation information indicates that the patient is experiencinghypoxemia. The output device may further be configured to initiate analarm if the oxygen saturation information falls below a predeterminedthreshold. The predetermined threshold may be based on at least one ofan age, height, weight, and gender of the patient. The one or moresensors may comprise a motion sensor configured to acquire motionsignals indicative of progress of the rescuer in performing the airwayintubation procedure.

The system may comprise electrocardiogram leads to acquire heart beatinformation of the patient. The one or more sensors may comprise acapnography sensor configured to acquire end-tidal CO2 (ETCO2)information from an airway of the patient. The one or more sensors maycomprise an oxygen sensor configured to acquire oxygen deliveryparameters from the airway of the patient. The one or more sensors maycomprise a flow sensor configured to acquire flow rate parameters froman airway of the patient. The one or more sensors may be integratedwithin an airway sensor module configured to be positioned in the airwayof the patient. The airway sensor(s) may be configured to be coupledwith a bag-valve mask for performing manual ventilations on the patient.

The medical system may provide parameters of the patient that includeoxygen saturation, expired carbon dioxide levels, and end tidal carbondioxide (ETCO2). The processor may be configured to automaticallydetermine whether preoxygenation has begun based on the changes invalues of the intubation parameters. The one or more intubationparameters may comprise at least one of an amount of oxygen detected byan oxygen sensor placed in an airway of the patient, and a flow rate ofgas in the airway of the patient. The processor is configured toautomatically initiate a preoxygenation timer in response to a start ofa preoxygenation step of the airway intubation procedure for guiding therescuer in providing an adequate amount of oxygen to the patient. Thefeedback generated by the output device may comprise an indication thatthe preoxygenation timer has expired. The processor may further beconfigured to automatically initiate a procedure timer in response to astart of an intubation step of the airway intubation procedure. Thefeedback generated by the output device may comprise an indication thatprocedure timer has expired. The output device is a display fordisplaying visual feedback. The display is a touchscreen displayconfigured to receive input from the rescuer.

The medical system further comprising a wrist-worn device that providesat least of visual and audible feedback to the rescuer. The wrist worndevice may comprise an accelerometer that detects motion of the rescuer.The medical system may comprise near-field communication transceivers onthe airflow sensor module and an ET tube to determine proximity ofairflow sensor module and the ET tube. The processor is configured toautomatically calculate drug dosage information of the patient inresponse to user entered information. The output device is configured todisplay the drug dosage information.

The processor may be configured to automatically generate and store inmemory event marker information in response to actions being performedby the rescuer. The output device may be configured to generate tonescoordinated with determined QRS complexes of the patient. The outputdevice may be configured to generate the tones in response to adetermination of a start of endotracheal tube placement in the patient.The frequency of each tone is based on a detected oxygen saturationlevel. The processor is configured to automatically verify an initiationof tube placement based on the one or more intubation parameters. Theone or more intubation parameters comprises a characteristic of airflowin the airway of the patient. The characteristic of airflow comprises atleast one of flow rate in the airway of the patient, ETCO2, and anamount of oxygen in the airway of the patient. The processor may beconfigured to start a procedure timer upon verification of theinitiation of tube placement. The feedback generated by the outputdevice comprises a display of the procedure timer. The feedbackgenerated by the output device comprises a display of oxygen saturationinformation of the patient. The processor may be configured toautomatically verify tube placement based on the one or more intubationparameters.

The processor may be configured to automatically verify that the patientis in proper position prior to tube placement and the output device isconfigured to provide feedback to the rescuers to move the patient to aproper position if the patient is not in a correct position forintubation.

In another example, a medical device for assisting a rescuer inperforming one or more steps of an airway intubation procedure on apatient is described. The system may comprise an oxygen sensorconfigured to be positioned in a path of the patient's airway and toacquire one or more oxygen delivery parameters, a capnography sensorconfigured to be positioned in the path of the patient's airway and toacquire ETCO2 of the patient. The system may include a flow sensorconfigured to be positioned in the path of the patient's airway and toacquire a flow rate in the patient's airway, at least one processorcommutatively coupled to the oxygen sensors and capnography sensor andconfigured to, analyze the one or more oxygen delivery parameters fromthe oxygen sensors, the capnography sensor, and the flow sensor, todetermine whether the patient is being properly ventilated based on atleast one of a detected amount of oxygen in the patient's airway, themeasured ETCO2 of the patient, and the flow rate in the patient'sairway; and an output device including a visual display and configuredto display feedback to the rescuers based on the acquired informationindicative of the amount of oxygen in the patient's airway, ETCO2, andthe flow rate in the patient's airway. Implementations of such a devicemay include one or more of the following features.

The oxygen sensor, the capnography sensor and the flow sensor may begenerally provided as separate components though, in certainembodiments, may be incorporated in an integrated airway sensor module.The processor may be configured to determine whether preoxygenation hasbeen initiated based on at least one of the amount of oxygen in thepatient's airway and the flow rate in the patient's airway. In someembodiments, the processor may be configured to begin a preoxygenationtimer based on the determination of whether preoxygenation has beeninitiated. The feedback on the output device comprises visual display ofat least one of the preoxygenation timer and an indicator of oxygenreserve (e.g., oxygen reserve index which provides an indication of thefullness of oxygen capacity of the patient). The processor may beconfigured to determine whether an intubation process has been initiatedbased on a change in at least one of an amount of oxygen in thepatient's airway and flow rate in patient's airway. The change in theamount of oxygen comprises a lack of change in oxygen concentrationdetected in the airway sensor. The change in the flow rate comprises alack of flow detected in the airway sensor. The processor may beconfigured to begin procedure timer based on the determination ofwhether the intubation process has been initiated. The feedback on theoutput device Implementations of such a patient support structure mayinclude one or more of the following features.

An oxygen saturation sensor may be to acquire information indicative ofoxygen saturation levels of the patient. The oxygen saturation sensorcomprises at least one of pulse oximeter and a near infrared tissueoxygen sensor. The feedback of the output device comprises visualdisplay of the oxygen saturation level of the patient. The feedback ofthe output device may be include an indication of whether the oxygensaturation level of the patient has met criteria for determining thatthe patient is at risk of being hypoxemic. The criteria for determiningthat the patient is at risk of being hypoxemic may comprise adetermination that the oxygen saturation level of the patient hasdropped below a predetermined threshold during intubation of thepatient.

The processor may be configured to determine whether an intubationprocess has been completed successfully based on a change in at leastone of flow rate in patient's airway, ETCO2 and change between theinspired and expired oxygen concentration. The feedback of the outputdevice comprises visual display of at least one of the oxygen saturationlevel of the patient and ETCO2. The output device may comprise anindication of whether the oxygen saturation level of the patient has metcriteria for determining that the patient is at risk of being hypoxemic.The criteria for determining that the patient is at risk of beinghypoxemic may comprise a determination that the oxygen saturation levelof the patient has dropped below a predetermined threshold duringmonitoring of the patient. Feedback of the output device of the ETCO2and air flow may comprise an indication of whether adequate ventilationis being performed for determining if the patient is at risk hypercarbiawith the criteria determined based on predetermined values for thesevalues based on clinical norms and patient information anthropometricdata.

Various aspects of examples of the system are set out in the claims.According to a first aspect of the present system, a ventilationmonitoring device comprises at least one processor and at least onememory including computer program code. The at least one memory and thecomputer program code are configured with at least one processor tocause the ventilation monitoring device to determine whether anintubated subject's tracheal tube is properly placed by receiving anindication of a subject's breathing from at least one sensor.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the disclosure are discussed below with reference tothe accompanying figures, which are not intended to be drawn to scale.The figures are included to provide an illustration and a furtherunderstanding of various examples, and are incorporated in andconstitute a part of this specification, but are not intended to limitthe scope of the disclosure. The drawings, together with the remainderof the specification, serve to explain principles and operations of thedescribed and claimed aspects and examples. In the figures, eachidentical or nearly identical component that is illustrated in variousfigures is represented by a like numeral. For purposes of clarity, notevery component may be labeled in every figure. A quantity of eachcomponent in a particular figure is an example only and other quantitiesof each, or any, component could be used.

FIG. 1A is a schematic illustration of an example of a medical system,including a medical device, electrode assembly, and rescuers providingmedical treatment to a patient prior to intubation.

FIG. 1B is a schematic illustration of an example of a medical system,including the medical device, electrodes, and endotracheal tube postintubation in accordance with an embodiment.

FIG. 2 is a block diagram of the medical system including components ofa medical device, a plurality of sensors capable of communicating withthe medical device, and a central facility in accordance with anembodiment.

FIG. 3A is a flow chart illustrating steps performed during rapidsequence intubation in accordance with an embodiment.

FIG. 3B is a flow chart illustrating steps performed during anintubation procedure involving less steps than that shown in FIG. 3A inaccordance with an embodiment.

FIG. 4A is an exemplary user interface (dashboard) of a medical devicein accordance with an embodiment.

FIG. 4B is an exemplary user interface (dashboard) of a medical devicefor treating a traumatic brain injury (TBI) patient in accordance withan embodiment.

FIG. 4C is an exemplary alternative user interface (dashboard) of amedical device for treating a traumatic brain injury (TBI) patient inaccordance with another embodiment.

FIG. 5 is a flow chart illustrating steps performed during adetermination of whether a patient needs rapid sequence intubation inaccordance with an embodiment.

FIGS. 6A and 6B are exemplary user interfaces of a medical device duringa determination of whether the patient needs intubation using rapidsequence induction.

FIG. 7 is a flow chart illustrating steps performed while preparing apatient for a rapid sequence intubation procedure in accordance with anembodiment.

FIGS. 8A and 8B are exemplary user interfaces (dashboards) displayed ona medical device during the preparation of a patient for rapid sequenceintubation in accordance with an embodiment.

FIG. 9 is a flow chart illustrating steps performed during thepreoxygenation of a patient during a rapid sequence intubation procedurein accordance with an embodiment.

FIG. 10A is an exemplary user interface displayed on a medical deviceduring the preparation of a patient for rapid sequence intubationshowing an alarm indication in accordance with an embodiment.

FIG. 10B is an additional exemplary user interface displayed on amedical device during an intubation procedure in accordance with anembodiment.

FIG. 11 is a flow chart illustrating steps performed during thepre-treatment and paralysis of a patient during a rapid sequenceintubation procedure in accordance with an embodiment.

FIG. 12 is an exemplary user interface displayed on a medical deviceduring the preparation of a patient for rapid sequence intubation inaccordance with an embodiment.

FIG. 13 is a flow chart illustrating steps performed during the patientposition steps of the rapid sequence intubation procedure in accordancewith an embodiment.

FIG. 14A is a flow chart illustrating steps performed during theplacement of an endotracheal tube during a rapid sequence intubationprocedure in accordance with an embodiment.

FIG. 14B is an exemplary user interface displayed on a medical deviceduring the tube placement of a rapid sequence intubation procedure.

FIG. 15A is an exemplary user interface displayed on a medical deviceduring the tube placement of a rapid sequence intubation procedure.

FIG. 15B is a diagram of a testing screen of a medical device showingtesting in progress, the medical device is configured in a manual modefor use with a capnography sensor and a protocol comprising threeauscultations according to an example embodiment.

FIG. 15C is a diagram of a testing screen on a medical device showingthe testing has passed, the medical device is configured in a manualmode for use with a capnography sensor and a protocol comprising threeauscultations according to an example embodiment.

FIG. 15D is a diagram of a testing screen on a medical device showingthat the testing has failed, the medical device is configured in amanual mode for use with a capnography sensor and a protocol comprisingthree auscultations according to an example embodiment.

FIG. 15E is a diagram of a testing screen on a medical device showingthat the testing has failed, the medical device is configured in amanual mode for use with a capnography sensor, and a protocol comprisingfive auscultations according to an example embodiment.

FIG. 15F is a diagram of a testing screen on a medical device showingthat the testing has failed, the medical device is configured in amanual mode for use with a capnography sensor, electrodes, and aprotocol comprising five auscultations according to an exampleembodiment.

FIG. 15G is a diagram of a testing screen on a medical device showingthat the testing has passed, the medical device is configured in anautomatic mode for use a capnography sensor, electrodes, and a protocolcomprising five auscultations according to an example embodiment.

FIG. 16A is a flow chart illustrating steps performed during theverification of endotracheal tube placement in accordance with anembodiment.

FIG. 16B is a flow chart illustrating exemplary steps performed duringthe post intubation verification in accordance with an embodiment.

FIG. 16C is a flow chart illustrating exemplary steps performed duringthe post intubation verification in accordance with an embodiment.

FIG. 16D is a flow chart illustrating alternative exemplary stepsperformed during the post intubation verification in accordance with anembodiment.

FIG. 16E is an exemplary user interface (dashboard) displayed on amedical device during tube verification and illustrates detection ofairflow by a flow sensor in accordance with an embodiment.

FIG. 16F is an exemplary user interface (dashboard) displayed on amedical device during the tube verification and illustrates thedetection of a breath from transthoracic impedance measured byelectrodes in accordance with an embodiment.

FIG. 16G is an exemplary user interface (dashboard) displayed on amedical device during the tube verification step and illustrates thedetection of a breath by a capnography sensor in accordance with anembodiment.

FIG. 16H is an exemplary user interface (dashboard) displayed on amedical device during the tube verification step and illustrates thedetection of a breath from both capnography sensor and electrodes inaccordance with an embodiment.

FIG. 16I is an exemplary user interface (dashboard) displayed on amedical device during the tube verification and illustrates the failureto detect a breath in accordance with an embodiment.

FIG. 17 is a flow chart illustrating steps performed during the postverification of endotracheal tube placement in accordance with anembodiment.

FIG. 18 is a flow chart illustrating steps performed during post-casedebriefing in accordance with an embodiment.

DETAILED DESCRIPTION

Rapid sequence induction (or intubation) is intended to be an effectiveprocedure for rapid placement of the endotracheal tube in a patient.Successful RSI implementation often uses the mnemonic “The 7 P's of RSI”to help rescuers remember each of the steps involved in the procedure.The 7 “Ps” include Preparation, Preoxygenation, Pretreatment, Paralysiswith induction, Protection and Positioning, Placement with Proof, andPost-intubation management. While some rescuers (or caregivers) may haveextensive experience performing intubation, other rescuers, may havelimited experience with the procedure and might not remember the exactorder of steps or all actions required to ensure a successful outcome.

Intubation is a time-sensitive procedure that can be quite dangerousand, thus, requires careful attention by the rescuer. The present systemis designed to optimize or otherwise enhance the rescuer's performanceand the patient's safety during the procedure. In general, the presentsystem is related to a medical airway management system that is designedto aid clinicians during intubation procedures, such as the rapidsequence intubation procedure, as discussed in further detail herein,amongst others. An advantage of the present system is that the systemprovides automated guidance and context-sensitive feedback throughoutthe steps of procedure. The system uses a variety of sensors toautomatically detect which steps are being performed, at any given time,and also identify when the rescuers have started a new step. Forinstance, and will be described in more detail below, medical devices(e.g., patient monitoring devices) for use in medical airway managementsystems in accordance with embodiments discussed may implement one ormore sensors for obtaining data indicative of one or more intubationparameters, where the intubation parameter(s) may be used by the airwaymanagement system to detect transition between steps in the RSIprocedure, or similar intubation procedure, based on changes in theintubation parameter value(s). The airway management system may alsopresent on a user interface an output to assist the rescuer inperforming the various steps of RSI, or similar intubation procedureinvolving some or all of the steps related to RSI.

As noted above, one or more sensors may be used to obtain informationfor one or more processors of the airway management system to estimateone or more intubation parameters relevant to the RSI procedure, oranother similar intubation/airway procedure. The intubation parameter(s)may include one or more gas parameters, one or more physiologicalparameters, one or more positioning parameters, and/or other relevantparameters.

In accordance with various embodiments, one or more gas parameters maybe used as intubation parameters employed by a patient monitoring deviceor other airway management system to assist a rescuer through the RSIprocedure, or another similar intubation/airway procedure (e.g., morelimited intubation procedure). The gas parameter(s) may include, forexample, oxygen (O2) concentration in the patient airway, carbon dioxide(CO2) concentration in the patient airway, gas flow rate, inspiratoryflow rate, expiratory flow rate, tidal volume, minute volume, airwaypressure, gas temperature, gas humidity, or other gas parameterscharacteristic of the patient airway, e.g., to determine which steps inthe overall procedure are being performed. Examples of sensors that maybe used to detect the gas parameter(s) may include an oxygen sensor formeasuring a concentration of oxygen in the patient's airway, a flowsensor for measuring gas flow rate in the patient's airway, acapnography sensor for measuring a concentration of CO2 in the patient'sairway, and/or other sensors configured to obtain information regardingthe patient airway and respiratory function. Such sensors may be usedalone or in combination with other sensors, or sensor types, for themedical system to provide context-sensitive prompting or information forthe rescuer.

In certain embodiments, physiological parameters may also be measuredand used as input for the airway management system as intubationparameters to determine which steps in the RSI procedure or otherintubation procedure are being performed. Examples of such physiologicalsensors include a pulse oximeter to measure oxygen saturation (SpO2) anda capnography sensor to measure expiratory CO2, typically presented as awaveform of expiratory CO2 vs. time (ETCO2). Other examples ofphysiological sensors that may be used in accordance with embodiments ofthe present disclosure include ECG sensors for obtaining ECG signalsfrom the patient, a microphone for obtaining acoustic information fromthe patient, impedance sensors for obtaining a transthoracic impedanceof the patient (e.g., ECG sensors and/or electrodes for administeringelectrical therapy may be used for obtaining transthoracic impedance orimages based on impedance), and noninvasive blood pressure sensors forobtaining blood pressure of the patient. The amplitude, rate, trend, andshape of the waveform will change based on changes in the patient'scondition.

In various embodiments of the present disclosure, positioning parametersmay be used as intubation parameters in a patient monitoring device orother airway management system to help a rescuer properly navigatethrough the RSI procedure, or another intubation procedure. Thepositioning parameter(s) may provide information having to do with therelative positions of the patient, rescuer, and/or equipment used in theprocedure. Various positioning parameters may include, for example,motion information, displacement, position information, velocity,acceleration, video information, and image information. Imageinformation may be captured, for example, by a camera located on or neara patient monitoring device, or a laryngoscope used in conjunction withthe RSI procedure where the video thereof is presented on the patientmonitoring device or other display of the airway management system.

A benefit of the automated detection of which steps in the procedure arebeing performed alleviates rescuers from having to manually adjustdisplay settings during the procedure or otherwise be distracted fromthe task at hand in treating the patient. Accordingly, embodiments ofthe present disclosure are useful to increase the likelihood that therescuers' focus remains on treating the patient throughout the procedurewhile also helping the rescuers' carry out each of the necessary steps.In some cases, the airway management system prioritizes certainintubation parameters to be displayed or otherwise communicated to therescuer(s) so that the most relevant information is readily accessible.

Thus, for example, when the patient is being manually ventilated duringpreoxygenation, an oxygen sensor for detecting the concentration ofoxygen in the patient's airway as a gas parameter may be used to detectthat oxygen is being administered to the patient. This oxygen detection(e.g., confirmed by exceeding a preset threshold) may act as a triggerfor the airway management system to determine that preoxygenation isoccurring. During preoxygenation, a patient monitoring device of theairway management system may display a trend of the patient's oxygensaturation (e.g., recorded via pulse oximetry, near infraredspectroscopy, or another suitable method) or oxygen reserve indicator orindex (discussed further below). If appropriately preoxygenated, thepatient's oxygen saturation levels may be at or near 100%. Then, duringtube placement when manual ventilation is halted for the time being, theoxygen saturation waveform is likely to change shape over time. Forexample, during tube placement, as the body takes up oxygen from theoxygen reservoir in the lungs, oxygen saturation will gradually decreaseto the point of more substantial desaturation. Further, duringintubation placement, certain intubation gas parameters (e.g., air flowand/or CO2 as detected by the airway and/or CO2 sensor(s)) may no longerbe present or detectable. The lack of other physiological parameters(e.g., ETCO2 or CO2 waveform as estimated from data collected from acapnography sensor) may also be indicative intubation parameters. Also,other physiological parameters, such as lung sounds (as detected by amicrophone or acoustic sensor positioned on the patient) and chest risebased on impedance detection (from electrode sensors placed on thepatient) will also no longer be present. This change in waveform can beused, along with other information discussed in the specification below,to determine when a next step has started.

In response to that detected new step, as discussed herein, the airwaymanagement system changes which intubation parameters are displayed onthe patient monitoring device to the rescuers. This ensures the rescuersare presented with the most relevant information at each point duringthe entire case to carry out an effective procedure, without requiringrescuers from having to manually adjust display settings during theprocedure, and helps to ensure that the rescuers' focus remains ontreating the patient throughout the procedure.

Additionally, the patient monitoring device of the airway managementsystem may be further configured to automatically verify that the tubeplacement procedure was successful and/or continue to verify that propertube placement is maintained. One common mode of failure duringintubation occurs when the rescuer inserts the endotracheal tube intothe patient's esophagus (i.e., the pathway to the stomach). Compoundingthat mistake, rescuers may then fail to continue monitoring of thepatient (e.g., inspecting the CO2 waveform) to verify whether the tubewas placed correctly and is appropriately delivering oxygen to thepatient and ensure that the intubation tube does not become dislodgedafter placement. One benefit of the present disclosure is that thesystem not only analyzes intubation parameters to determine when stepsare being performed, but the system also verifies that the measuredsignals are consistent with successful tube placement (on initialplacement and also to confirm that the tube remains properly placedduring post-intubation monitoring) and that the patient is able toremain hemodynamically stable during and after the procedure. After thetube is placed and the patient is being monitored, the system maycontinue to verify that the tube is properly placed. For example, thesystem may employ a flow sensor to detect airflow in the patient airway(e.g., airflow from the ventilation apparatus such as bag-valve mask,ventilator, etc.) and then initiate a timer to receive physiologicalinformation that confirms that the ventilation airflow has reached thepatient's lungs (as opposed to the esophagus) within the specified timeinterval. Such physiological information may be obtained, for example,from a capnography (CO2) sensor, impedance detection via electrode pads,an acoustic sensor that is able to detect the sound of air entering thepatient's lungs, and/or another appropriate manner. In the event theyare not, context-sensitive alarms alert the user and provide aprioritized list of clinical actions required to safely manage thepatient.

In various embodiments of the present disclosure, one or more componentsof the airway management system may include one or more airway sensorsfor measuring data indicative of gas parameters characteristic of gasflowing or otherwise present in the patient airway. As discussed,signals measured by the airway sensor(s) during both inspiration andexpiration may include one or more of the following gas parameters:oxygen (O2) concentration, carbon dioxide (CO2) concentration, gas flowrate, inspiratory flow rate, expiratory flow rate, tidal volume, minutevolume, airway pressure, gas temperature, gas humidity, etc. The one ormore airway sensors may be coupled to a patient monitoring device suchthat, while the patient is being monitored, the data from the sensors iscontinuously communicated to the patient monitoring device. The patientmonitoring device comprises one or more processors configured tocontinuously receive the data indicative of gas parameters and processthe data to generate values. In certain embodiments, in addition to thesensor(s) and processor(s) for measuring gas parameters, processingresources (e.g., in the, patient monitoring device, sensor(s)themselves, or other medical device) are able to calculate additionalmeasurement parameters that may include: breath volume, breathing rate,O2 consumption, CO2 elimination rate, respiratory quotient, airway leakand other calculated values. In addition, the airway management system(e.g., one or more processors incorporated in a patient monitoringdevice) are configured to perform detailed signal waveform analysis toidentify clinically significant patterns indicative of physiologic orairway gas measurement conditions and/or system/sensor faults thatrequire user attention or intervention.

In certain embodiments, one or more airway sensors may be incorporatedin a more integrated airway sensor module provided with the manualventilation device (e.g., bag-valve mask). One benefit of such anarrangement is that rescuers may fail to place, e.g., the CO2 sensor(capnography sensor) or are delayed in placing it. By having certainsensors integrated into a single manual ventilation device (e.g.,bag-valve mask) that engages with the patient, the airway managementsystem will monitor multiple intubation parameters such as CO2, O2, andflow rates and pressure anytime a ventilation bag is used. However, itshould be understood that various sensors may be positioned at differentlocations on or near the patient. For example, an oxygen sensor, acapnography sensor and/or a flow sensor may be placed in the patientairway or at side stream locations of the patient airway for obtaininginformation to estimate relevant gas parameters characteristic of thepatient airway.

Medical System Overview

FIG. 1A is a schematic illustration of an example of an airwaymanagement system 100, including a medical device 202 (e.g., patientmonitoring device such as an automated external defibrillator orprofessional style monitor/defibrillator), electrode assembly 110, andrescuers 104, 106 providing medical treatment to a patient 102 prior tointubation. While several embodiments presented herein describe themedical device 202 as implementing the processor(s) for analyzing datafrom the sensor(s), determining next steps in the RSI procedure, andproviding output via a user interface, it can be appreciated that otherportable computing devices such as a tablet or other computing devicemay perform steps in accordance with the present disclosure.Additionally, the portable computing devices may be used in conjunctionwith medical device 202.

In this example, rescuers 104, 106 are in position and providing care tothe patient 102, with rescuer 104 providing chest compressions to thetorso of the patient 102, and rescuer 106 providing ventilation usingventilation bag 112, which is connected to a ventilation valve 113 and amask 115. Collectively, these components (112, 113, 115) are oftenreferred to as a bag-valve-mask or (BVM). While not illustrated, the BVMis often connected to a source of “medical oxygen,” which is used as anoxygen supply to the bag 112, so that oxygen can be delivered duringventilation.

Generally, the rescuers 104, 106 may be lay-rescuers who were near thepatient 102 when the patient required care, or may be trained medicalpersonnel such as doctors, firefighters, paramedics, combat medics, oremergency medical technicians, for example. Although two rescuers 104,106 are illustrated, in alternative embodiments additional rescuers (notshown) may also be involved in treating the patient or only one rescuermay provide treatment. As used hereinafter, the term rescuer maygenerally be understood to include a person that is aiding in acute caretreatment of the patient 102 during an emergency medical situation, andmay be actively engaged in resuscitation activity of the patient, suchas in providing cardiopulmonary resuscitation. Additionally, similarterms such as clinician, user, or caregiver are generally understood tobe interchangeable when used herein to describe a person giving acutemedical and/or resuscitative aid to the patient.

Additionally, while the present system is described with respect to aBVM and manual ventilations, a portable automatic ventilator could beused to provide oxygen and ventilate the patient. The EMV+® or Z Vent™,both manufactured by ZOLL Medical Corporation of Chelmsford, Mass. areexamples of portable ventilators. Likewise, the rescue scenario mayoccur in a hospital or ambulance where an automatic ventilator may alsobe available (e.g., ZOLL 731 Ventilators provided by ZOLL® MedicalCorporation).

Control and coordination for the medical event is typically controlledby the medical device 202. In a typical implementation, the medicaldevice 202 is a defibrillator, automated external defibrillator (AED),ventilator system, or medical patient monitor, to list a few examples.Alternatively, the medical device 202 could even be mobile computingdevice such as a tablet-based computer, smartphone, or wearablecomputing and interface device (e.g., smart watch or head mountedoptical display) that is controlled by the rescuers 104, 106, forexample, in coordinating resuscitation activities, evaluating orotherwise communicating with on-site and/or remote medical personnel, orotherwise providing information useful for the rescuer(s) in treatingthe patient.

The medical device 202 is connected to an electrode assembly 110 via awired connection 119 from the medical device to the electrode assembly110. In this implementation, the medical device (e.g., defibrillator, orpatient monitor) may take a generally common form, and may be aprofessional style defibrillator which may also function as a medicalmonitor, such as the R-SERIES®, X-SERIES®, M-SERIES®, or E-SERIES®provided by ZOLL® Medical Corporation of Chelmsford, Mass., a ventilator(e.g., portable ventilator), such as the 731 Ventilator provided by ZOLLMedical Corporation, or an automated external defibrillator (AED), suchas the AED PLUS®, or AED PRO® provided by ZOLL Medical Corporation.

In addition, the medical device 202 could take the form of an integratedsystem of devices (defibrillator, vital signs monitor, ventilator, ormechanical CPR chest compression device, for example) with either acomposite, single-system embodiment or one that uses a series ofdiscrete devices that are dynamically integrated through wired and/orwireless communication to function as a single integrated system.

This optionally wired connection 119 enables data from sensors in theelectrode assembly to transmit information to the medical device 202,and the wired connection 119 also allows energy to be sent from themedical device 202 to the electrode assembly 110, in scenarios in whichthe medical device is a defibrillator or automated externaldefibrillator. In alternative embodiments, for example, in scenarios inwhich the medical device is a tablet or monitor, the wired connectionmay be replaced with a wireless connection. While not expressly shown inthe figures, the BVM component(s) as well as other treatment and/orsensing devices (e.g., oxygen saturation sensors, accelerometers, airflow sensors) may also be communicatively coupled with the medicaldevice 202. For example, in embodiments where the BVM incorporatessensors (e.g., oxygen sensor, capnography, flow sensor, air flowmodule), such sensors may be in communication with the more centralmedical device 202. As noted herein, sensors for obtaining data relevantto gas parameters characteristic of the patient airway may be providedas separate components, or may be integrated together into a singlecomponent.

The electrode assembly 110 is shown on the patient 102 in a typicalposition. The electrode assembly 110, in this example, is an assemblythat combines an electrode positioned high on the right side of thepatient's torso, a separate electrode positioned low on the left side ofthe patient's torso, and a sensor package located over the patient'ssternum. The electrode assembly 110 may further include a sensorpackage, which, in this example, is obscured in the figure by the handsof rescuer 104. This sensor package may include a motion sensor (e.g.,accelerometer(s), velocity sensor, distance sensor) or similar sensorpackage that may be used in cooperation with a computer in the medicaldevice 202 to monitor performance (e.g., compression depth, compressionrate, and release) of the chest compressions, patient movement orpositioning. Additionally, a microphone may also be included with, orseparately from, the electrode assembly 110 to obtain auscultation data(e.g., acoustic signals) of internal sounds of the patient 102. Themicrophone may be used to obtain signals related to heart sounds,breathing sounds or gastric sounds, for example.

In the illustrated example, the medical device 202 communicateswirelessly with the wrist-worn devices 120, 122 to present informationand/or guidance to the rescuers 104, 106. For example, informationrelated to chest compressions, heart rate, or other relevant information(e.g., SpO2, ETCO2) related to the intubation process can be visuallypresented on the displays 121, 123. Additionally, vibration componentsand/or audible sound generators on the wrist-worn devices 120, 122 canprovide feedback. Such feedback, as discussed more fully below, mayinclude information about physical status of the patient 102, guidanceand feedback related to ventilation or cardio pulmonary resuscitationsof the patient 102, and/or specific context-sensitive or prioritizedinstructions to perform critical interventions/tasks to ensure patientsafety or optimal therapeutic management. Haptic and audible feedbackmay have the added benefit of providing a notification to the rescuerwhile not requiring the rescuer to divert his/her attention from thetask at hand. This is as opposed to a visual display, which wouldtypically require the rescuer to turn his/her head to view whatever ispresented on the visual display.

The wrist-worn devices 120, 122 can be smart watches (e.g., computerizedwristwatches with functionality enhanced beyond timekeeping) or otherwrist worn wearable technology, such as fitness trackers. Such a smartwatch can effectively be a wearable computer. The smart watch caninclude a data processor, memory, input and output. The wrist-worndevices 120, 122 may be equipped to collect information gathered frominternal sensors (e.g., an accelerometer, hear rate monitor, pulseoximetry sensor, or colorimeter, to list a few examples), via directcommunication therewith or through a separate medium (e.g.,defibrillator, monitor, external computer). The smartwatches may also beable to control or retrieve data from each other, other instruments orportable computing devices 225 (shown in FIG. 2), or the medical device202. Typically, the smartwatch can support wireless technologies, likeBluetooth, 3G/4G cellular network, and/or Wi-Fi, to communicate with themedical device 202 or the other computing device. In other examples, thesmartwatch may just serve as a front end for a remote system and beconfigured to display information generated by the medical device 202.The displays 121, 123 in the wrist-worn devices 120, 122 can be made ofIndium gallium zinc oxide (IGZO), a semiconducting material. IGZOthin-film transistors (TFT) can be used in the TFT backplane offlat-panel displays (FPDs). Because the IGZO display is flexible, agreater amount of information can be displayed on the wrist-worn devices120, 122 due to the increased surface area of the display. Additionally,the display of the wrist-worn devices may be touchscreen displays, whichenables user control, selections, and input via interaction with thedisplay. Alternative embodiments may use other display technology, suchas flexible organic light emitting diodes (flexible OLED).

In still yet another embodiment, the rescuers may use head-mountedheads-up display systems (not shown). The benefit of wearable heads-updevices is that they allow focus to remain on the patient 102 while atthe same time providing a continuous interface to relevant data.

FIG. 1B is a schematic illustration of an example of the airwaymanagement system 100, including the medical device 202, electrodes, andendotracheal tube 129 post intubation. That is, during post-intubation,the ET tube has been placed in the trachea of the patient and thepatient is being physiologically monitored while ventilations areadministered (e.g., by a BVM or ventilator).

In general, a tracheal tube is a catheter that is inserted into thetrachea of patient 102 to establish and maintain an open airway and toensure adequate exchange of oxygen and carbon dioxide. An endotrachealtube, such as the endotracheal tube 129, is a specific type of trachealtube that is usually inserted through the patient's mouth or nose. Manyairway tubes such as an endotracheal tube 129 may be used withembodiments of the present device to provide a patent airway forventilation and monitoring.

The ventilation bag 112 is coupled to the ventilation valve 113. Asshown in this example, the mask is no longer required once theendotracheal tube is inserted into the patient. In accordance withembodiments of the present disclosure, one or more airway sensors 127(e.g., may include one or more of oxygen sensor, capnography sensor,flow sensor, etc.) may be situated between the ventilation bag 112 andthe endotracheal tube 129 to allow monitoring of the inspiratory andexpiratory gas, for example, as a result of manual ventilation performedusing the ventilation bag 112, and/or monitoring of patient breathing.As is typical, the ventilation bag 112 and valve 113 allow the rescuerto actively ventilate the patient 102 by squeezing the bag or for thepatient to spontaneously breathe, while in both instances the patient'sexhaled gas exits back through the valve allowing for bidirectionalmonitoring. Alternatively, the ventilation bag 112, may be augmented toprovide supplemental O2 from a separate O2 source (e.g., oxygen tank).

In the illustrated embodiment, the airway sensor(s) 127 includes one ormore sensors to measure various physiologic and/or airway gasmeasurement signals during both inspiration and expiration thatincludes: oxygen (O2), carbon dioxide (CO2), gas flow rate and volume,airway pressure, gas temperature, and gas humidity, to list a fewexamples. Additionally, processing resources in either the airwaysensor(s) 127 or medical device 202 are able to calculate additionalphysiologic and/or airway gas measurement parameters such as breathvolume, breathing rate, O2 consumption, CO2 elimination rate,respiratory quotient, airway leak and other calculated values, forinstance.

Communication cable 117 may be any type of communication cable or set ofwires, which allows data exchange between the medical device 202 and theairway sensor(s) 127 such as but not limited to an RS-232 cable,Universal Serial Bus (USB) cable or Ethernet cable. Communicationbetween the medical device 202 and the airway sensor(s) 127 could alsobe wireless communication such as IEEE 802.11 wireless local areanetwork (WLAN) or low-power radio frequency (RF) communication such asBluetooth, to list a few examples.

Electrodes 125 a and 125 b are electrically coupled to the medicaldevice 202 using cables 121 a and 121 b. Electrodes 125 a and 125 b arepositioned across the subject's thoracic cavity and attached to thesubject, one electrode anterior and the other electrode posterior to thepatient, for example. In the embodiment, electrodes 125 a and 125 b arecapable of measuring an electrocardiogram (ECG) signal from the patient.The electrodes 125 a and 125 b may also be suitable electrodes formeasuring a transthoracic impedance of a subject. In some embodiments,the electrodes 125 a, 125 b may be high-voltage electrodes capable oftransmitting electrotherapy to the patient, such as for electricaldefibrillation and/or cardiac pacing treatment.

The medical device 202 is configured with electrodes 125 a and 125 bthat are capable of providing therapeutic shocks, if needed, as well asto monitor changes in the transthoracic impedance of the patient 102. Ifthe endotracheal tube 129 is properly placed in the subject's tracheaand the subject's lungs are ventilated using a ventilation bag 112 andvalve 113 (or via a mechanical ventilator), then the medical device 202detects a change in impedance across the subject's thorax betweenelectrodes 125 a and 125 b. If the endotracheal tube 129 is not properlyplaced; for example, it was placed in the subject's esophagus, or hasbecome dislodged, the medical device 202 will detect that the impedancechange across the subject's thorax does not indicate that effectiveventilation is being administered, and may alert the user with acontext-sensitive alarm message using audible and/or visual alarmindicators on the medical device 202. Alternatively, or in addition, acapnography sensor is provided in the patient airway (e.g., mainstreamor sidestream). In this embodiment, if the endotracheal tube 129 isproperly placed in the subject's trachea, then the medical device 202detects CO2 (e.g., end tidal CO2 or ETCO2) indicative of proper tubeplacement; and if the endotracheal tube 129 is not properly placed orhas become dislodged, the medical device 202 will fail to detect CO2waveform indicative of proper intubation, and may alert the user with acontext-sensitive alarm message using audible and/or visual alarmindicators on the medical device 202. The medical device 202 may be incommunication with other devices, such as wrist-worn devices 120, 121,heads up display devices, for example, for alerting the necessarycaregiver(s).

FIG. 2 is a block diagram of the airway management system 200, includingthe medical device 202, airway sensor(s) 127, device sensors 210-222,which measure intubation parameters, peripherals (e.g., ventilator 223and portable computing device 225), and a central facility 224. Themedical device 202 typically includes a processor 204 for executinginstructions of software running on the medical device 202, memory 209to store the software and sensor information received from the sensors,a signal acquisition unit 208 to receive sensor information from thesensors 210-222, and an output device 206 to provide feedback to therescuers, which is typically a display. The output device 206 mayfurther include one or more speakers for providing audible feedback, orother components for providing other types of feedback, such ashaptic/tactile. Generally, a suitable display can be made from a widevariety of materials as described above. Additionally, the screen may betouchscreen display, which is a combined input/output device, whichenables user interaction of the medical device 202 by touching theoutput device 206.

Additionally or alternatively, the airway management system 200 mayfurther include a portable computing device 225 (e.g., tablet,smartphone, laptop computer) in communication with the medical device202. In one example, the portable computing device 225 may mirror thedisplay of the medical device 202, or may provide a secondary display ofinformation relevant to the user of the portable computing device 225.For instance, in certain situations, the activities of different usersat the emergency scene may differ, hence, it may be preferable for eachof the displays (e.g., on the medical device, on the portable computingdevice, on another device, etc.) to differ according to the jobperformed by the associated user. Additionally, the portable computingdevice 225 may include general information (e.g., dosage charts),medical procedure checklists, and/or other protocols that are typicallyused during an intubation procedure. Additionally, it may includeadditional checklists and/or protocols for other medical situations(e.g., instructions on the performance of CPR, or instructions on how toassemble the BVM, how to hook the patient up the ventilator, etc.) . . .). Additionally, the portable computing device would provide a qualityassurance report that includes: a list of completed and uncompletedtasks, the time tasks where completed, the required time for each tasks,event markers, alarms that occurred, relevant physiologic data as wellas other data that demonstrates the performance of the procedure.

Additionally, the portable computing device 225 may include the abilityto allow the user to enter patient information (e.g., height, weight,and gender) via a touchscreen display. The portable computing device mayalso include internet connectivity (e.g., via Wi-Fi or 3G/4G wirelessmobile telecommunication networks) to enable the rescuer to accessadditional patient information from the central facility, for example.

Respiratory gas monitoring provides a noninvasive method to monitor arange of physiologic or airway gas measurement data that indicates thepattern of ventilation, its effectiveness, the patient's metabolicstate, endotracheal tube placement and cardiopulmonary functioning. Thepresent system embodies a multifunction sensor module; however, themedical device 202 is also capable of providing the performance using aseries of individual sensor modules to measure O2 and CO2 gasconcentrations, gas flow and airway pressure.

An oxygen sensor 210 typically measures the amount of oxygen present inthe flow of gas through the patient's airway may be used to measure gasparameters in accordance with the present disclosure. The oxygen sensormay be equipped to measure the proportion of oxygen in the gas beinganalyzed. An example of an oxygen sensor that may be incorporated as anairway sensor is the Fibox 4 trace provided by PreSens Precision Sensingfrom Regensburg, Germany. According, when the oxygen sensor is placed inthe patient airway, a percentage or amount readout of oxygen that ispresent within the airway may be recorded. In one embodiment, the oxygensensor is attached to an inner surface of another airway sensor, such asa flow sensor or capnography sensor, or may be located elsewhere alongthe patient airway. Oxygen is measured contactless through a transparentvessel wall. Preferably, the sensor has a measurement range of 0-100%oxygen. In an embodiment, an oxygen sensitive coating may be immobilizedon a 125 μm flexible transparent polyester foil. In addition, the sensorcould also use other oxygen measurement methods such as a galvanic cellor paramagnetic techniques for example.

A pulse oximeter 212 provides a measurement of the oxyhemoglobinsaturation of the patient may be used to measure physiologicalparameters in accordance with embodiments described herein. Typically,the pulse oximeter is attached to the patient's finger, but could alsobe attached other locations (e.g., finger, palm, toe, sole or ear, forexample). In such cases, the sensor is typically placed at a thin partof the patient's body, such as the fingertip or earlobe, and the devicepasses multiple wavelengths of light through the body to a photodetectoron the other side. The changing absorbance at each of the wavelengthsmay allow for the medical device/sensor to determine the respectiveabsorbance due to pulsing arterial blood. Alternatively, or in addition,a near infrared sensor for measuring muscle oxygenation content andtissue pH could also be implemented to determine levels of monitor theeffectiveness blood flow and tissue oxygenation. Rather than detectionthrough transmission, the reflectance of the multiple wavelengths oflight by thicker tissues allow for levels of oxygen at that location tobe measured. In the illustrated example, the electrocardiogram sensors214 are part of the defibrillator electrodes and measure electricalactivity of the patient's heart, although it can be appreciated that ECGleads separate from the defibrillation electrodes may be employed. Anaccelerometer 216 or other motion sensor may be employed to measuremovements of the patient and/or rescuer, for example, in moving thepatient or apply chest compressions to the patient. In alternativeembodiments, the motion of the patient could be sensed by a sternalcompression sensor, which is part of the electrode assembly 110 or aseparate component entirely. Additionally, the accelerometer could belocated on the tube 129 (e.g., at a proximal location) or the rescuers104, 106.

A flow sensor 221 for measuring the flow rate and volume of air flowingthrough the patient's airway may be used to measure gas parameters inaccordance with various embodiments. The flow sensor 221 is typicallylocated within the airway of the patient, in fluid communication withthe portable ventilator or BVM 223. The flow sensor may be incommunication with the medical device and, hence, may provideinformation concerning the flow rate and volume in the patient's airway.Any suitable flow sensor may be employed, such as for example, adifferential pressure sensor. The flow sensor may be similar to thatdescribed in U.S. Patent Publication 2017/0266399, entitled “Flow Sensorfor Ventilation,” which is hereby incorporated by reference in itsentirety. Accordingly, the flow sensor may provide measurements ofinspiratory flow to the patient (e.g., provided by positive pressurebreath ventilations) and expiratory flow from the patient (e.g., airbreathed out from the patient).

One or more airway sensors 127 may be employed, for monitoring variouscharacteristics of the air flow within the patient's airway. The airwaysensor(s) may include a capnography sensor. For example, the capnographysensor may be equipped to measure gas parameters, such as theconcentration and partial pressure of carbon dioxide (CO2) in therespiratory gases of the subject. Signals/data from the capnographysensor may be further processed to determine physiological parameters,such as end-tidal CO2 of the patient. In addition, the airway sensor(s)may include a flow sensor that communicates information related to thesubject's inspiratory and expiratory gas flow. The airway sensor(s) mayfurther communicate information related to the concentration and partialpressure of respiratory gases, oxygen and water vapor for example. Asdiscussed herein, the airway sensor(s) may include, for example,capnography for measuring CO2, an oxygen sensor for measuring the amountof oxygen, and/or a flow sensor for measuring the rate and volume offlow within the patient's airway, separate or integrated together.

While the illustrated embodiment identifies certain types of sensors,those skilled in the art will recognize that additional sensors could beimplemented as well. Likewise, while the specification identifiesspecific intubation parameters in describing various examples of presentsystem, alternative sensors which perform identical or similar functionsmay be implemented for enabling the medical device to determine whethersteps in an airway management procedure have or have not been completed,for effectively assisting the rescuer in properly carrying out theprocedure.

The medical device 202 may include additional components such as amicrophone 220 to capture acoustic information of the patient 102 suchas the sounds of the patient breathing, or sounds of their heartbeating. Additionally, or alternatively, the medical device may furtherinclude one or more microphones to capture voice commands from therescuers 104, 106.

Furthermore, a video laryngoscope 222 is also connected to the medicaldevice 202, which may provide information used as a positioningparameter for the airway management system to determine the current stepin the RSI procedure. Laryngoscopes enable rescuers to look at the backof the throat (oropharynx), voice box (larynx) and identify the vocalcords, which provide the critical landmark for insertion of anendotracheal tube into the trachea. Use of a video laryngoscope aids theuser in visualizing critical anatomy while also allowing a range ofpatient-rescuer positions from which to view the airway and insert theendotracheal tube. Additionally, the video laryngoscope provides for adigital recording of the procedure that allows for secondaryconfirmation of tube placement and post-case review. In an alternativeembodiment, the digital recording from the laryngoscope would allow foruse of image analysis that could provide additional confirmation thatthe endotracheal tube was properly placed.

In one embodiment, the medical device 202 communicates with a centralfacility 224. The communication between the central facility 224 andmedical device may be via wireless technologies, like Bluetooth, orwireless telephone networks (e.g., 3G/4G wireless mobiletelecommunication networks), or possibly even the Enhanced 911 (or E911)network. The wireless networks are typically secured that requirepassword authentication to access the wireless network. The centralfacility 224 may be third-party location that stores and/or analyzesinformation received from the medical device 202. The central facilityis generally an emergency response center (e.g., 9-1-1 dispatch),back-end component such as a server, hospital, or ambulance, to list afew examples.

FIG. 3A is a flow chart illustrating steps performed during an exampleintubation procedure (possibly rapid sequence intubation or RSI) inaccordance with an embodiment. Specific embodiments, and detailedimplementation are discussed below. Additionally, while the embodimentsdescribed herein are directed to tracheal intubation, aspects of thepresent disclosure may also apply to other methods of intubation (e.g.,nasal intubation, intubation after performing a tracheotomy, emergencyintubation procedures, amongst others). In general, the medical device202 is able to identify which steps are being performed based on acombination of storing information related to which steps have alreadybeen performed, and which steps need to be performed. The device isfurther able to analyze changes in sensor data, and monitor actionsbeing performed on the patient. Illustrated by way of non-limitingexample, an advantage of airway management system is the ability toidentify when tube placement begins based on the completion of stepsleading up to tube placement (and the associated sensor data). Inaddition, information obtained from the sensors (e.g., intubationparameters such as oxygen (O2) concentration, carbon dioxide (CO2)concentration, gas flow, airway pressure, gas temperature, gas humidityas well as other physiologic and environmental data) are able to provideindications of caregiver progress in the intubation procedure, forexample, the pausing in ventilations (e.g., due to a drop in oxygenpresence/flow). In some embodiments, the temporary ceasing ofventilations coupled with image analysis of images captured by thelaryngoscope 222 can be analyzed as a whole by the medical device todetermine that the tube placement has begun. That is, in an example,while a lack of oxygen detected by the oxygen sensor may be anindication that ventilations have paused and the tube placement processhas begun, video footage from the laryngoscope may be used as aconfirmation of tube placement. Additionally, as shown in theillustrative embodiment, by way of example, steps which are required tobe performed by the rescuers are denoted by dotted lines (e.g., step 308and the manual ventilation and preoxygenation).

In a first step 300, the rescuer is optionally able to place the medicaldevice 202 into a practice/training mode in step 301. This practice modeenables rescuers 104, 106 to practice using the medical device,attaching sensors, prior to using the device in a real-world emergency.Additionally, the device may also include simulations of an emergencysituation that allows the rescuers to practice their response tochanging medical emergencies. For example, while in practice mode, themedical device 202 displays an alarm indicating that an airway leak hasoccurred. In this practice mode, the rescuers would then be required tofix the problem (e.g., check the BVM for a bad connection or faultycomponent). Thus, the rescuers would be able to practice both theprocedure as well as be able to more effectively troubleshoot commonproblems that can arise an emergency situation. Structured, regularpractice that focuses on procedures, physical skills, use of the tools,and communication between rescuers is essential to ensuring andmaintaining competency. In addition, the practice mode provides fordigital documentation and scoring, e.g. performance time, taskcompletion/failure, etc., of rescuer performance enabling formalobjective documentation of rescuer readiness and skills maintenanceactivities.

In the next step 302, the medical device receives and analyzes sensorinformation to determine whether intubation is needed. The medicaldevice 202 analyzes the received sensor information to identify commonsymptoms of acute respiratory failure including lack of breathing,agonal breathing, or gasping, to list a few examples. In this case, ifthe medical device determines that intubation is the best course ofaction given all of the information provided, it may display a messageon its screen that suggests to the user that intubation may be requiredand/or the medical device may automatically proceed to the next step inproviding further guidance in the overall intubation process.

Illustrated by way of a non-limiting example, information obtained bythe airway sensor(s) 127 may be indicating to the medical device 202that ventilation is being performed on the patient and/or oxygen isflowing to the patient, but the pulse oximeter 212 and capnographysensor 218 may indicate that the patient 102 is not adequately receivingthe O2 or exhaling CO2. With this information, the medical device 202 isable to identify a range of possible conditions whereby the patient isnot receiving adequate ventilation and/or oxygenation, which wouldresult in a context-sensitive alarm that offers a prioritized list ofconditions and associated interventions that the user should take tosafely manage the patient and correct the failure. For example, if thedevice detects that manual ventilation is being administered to thepatient (e.g., via signals from a flow sensor and/or oxygen sensordisposed within the patient airway), yet the breaths are shown not to beeffective (e.g., the expired volume is not equal to the inspired volumeand while oxygen is being administered, a significant drop in oxygensaturation levels is detected), then the medical device 202 may providean indication or suggestion that there is a mask leak and the usershould reposition the mask to ensure an adequate seal and breathdelivery.

As medical and/or emergency situations are often chaotic andunpredictable, the rescuers 104, 106 will be able to override thediagnosis and recommendations of the medical device 202. Illustrated byway of example, a faulty or improperly placed sensor or leaking airwaytube may generate data that is indicative that intubation is needed,while the rescuers 104, 106 own analysis and diagnoses arecontradictory. In these types of situations, the rescuers 104, 106 willbe able to override the medical device 202. Similarly, rescuers mayarrive on-scene where a patient has already been intubated (without themedical device of the present system). In this case, the rescuers maysimply wish to verify the placement of the tube and monitor the patientwhile they provide additional therapy or transport the patient. In thissituation, the rescuers are able to skip to the relevant step in theprocedure, e.g., post intubation monitoring (e.g., step 328).

Alternatively, in extreme situations where advanced medical personnel isnot available, but time is of the essence, then rescuers with limitedskills or experience may attach the plurality of the sensors 218 of themedical device 202, and based on sensor inputs provided to the medicaldevice, the medical device may assist the rescuer in a differentialdiagnosis and/or may guide him/her through the entire procedure step bystep, while simultaneously verifying that each step has been donecorrectly.

Returning to step 302, if it is determined that intubation is not needed(e.g., automatically by the medical device based on sensor inputs, orvia a user input), then the medical device 202 returns to a maindashboard interface in step 304. If, however, it is determined that thepatient 102 does need intubation, then the medical device 202 makes adetermination whether the patient is hemodynamically stable in step 303.In general, a patient is hemodynamically stable if they show positivesigns of healthy and effective blood circulation. In the present system,the medical device analyzes data from a combination of sensors (e.g.,ECG, blood pressure, capnography, oxygen saturation, and airway flow) todetermine if the person's heart function is normal and whether there isnormal blood circulation at the extremities. For example, if the ECGsignals exhibit regular QRS complexes indicative of depolarization ofthe right and left ventricles in a manner that would be expected toresult in healthy blood flow to and from the heart, the medical devicemay determine that the patient is hemodynamically stable. Additionally,a non-invasive blood pressure may be taken via an automated bloodpressure cuff (not illustrated). If the blood pressure of the patient iswithin acceptable limits (e.g., 90-120 systolic and 60-80 diastolic),then it may be an indication that the patient is more likely to behemodynamically stable.

If the patient is determined not to be hemodynamically stable, then themedical device may be configured to recommend to the rescuer that chestcompressions be given and/or automatically present a cardiopulmonaryresuscitation (CPR) chest compressions dashboard or interface to guidethe rescuers through chest compressions and possibly defibrillation instep 305. It should be noted, however, there are some patients that arenot hemodynamically stable, but that do not require chest compressions(e.g. they need pharmacologic intervention and/or fluid resuscitation).In such a case, the rescuer may provide an input to the medical devicethat overrides the interface for guiding the rescuers toward theadministration of chest compressions, and instead may administer theappropriate medication/fluids. Similarly, while accessing or utilizingthe CPR dashboard in step 305, it may be detected by the medical device202 (or become apparent to the rescuers who may provide an associatedinput to the medical device 202) that the patient requires an immediateintubation in response, without requiring all of the RSI steps describedherein. In one example, the medical device (or rescuers) may detect SpO2or ETCO2 values that indicate that oxygen is not reaching the patient'sextremities and/or sufficient CO2 not being expelled from their lungs,respectively. In this situation, the medical device would automatically(or in response to an input from the rescuers) skip to step 314 toposition the patient in order to begin the intubation procedure. FIG. 3Bprovides a flowchart illustrating the steps for a more limited protocolintubation. In some embodiments, a rescuer may simply bypass varioussteps of the overall RSI procedure by user input. For example, therescuer may decide that there is insufficient time for a fullpreoxygenation procedure or drugs to be administered to the patient and,hence, may choose to bypass such steps or indicate that the steps werenot carried out. Such decisions may be noted by the medical device andintegrated into the patient care record.

If the patient is hemodynamically stable, then the patient 102 isprepared for intubation in step 306. As part of the preparation forintubation, shown in the next step 308, manual ventilation andpreoxygenation of the patient begins to ensure that the patient isadequately hyperoxygenated prior to starting the procedure. In a typicalimplementation, immediately prior to intubation, the patient should beventilated and preoxygenated for at least 3 minutes (e.g., 30 or morebreaths) or for a longer period of time, e.g., 3 to 8 minutes. Thepurpose of this preoxygenation is to “fill” the patient lungs withoxygen while also expelling as much nitrogen as possible out of theirlungs to create a “reservoir” to meet the metabolic oxygen demand duringthe apneic period as the endotracheal tube is placed. The medical device202 automatically monitors the duration of ventilation as a gasparameter based on signals (e.g., flow rate and volume from flow sensor,presence of oxygen from oxygen sensor) from the airway sensor(s) whileat the same time tracking the SpO2 signal as a physiological parameterto an increase consistent with preoxygenation. When the criteria forpreoxygenation are achieved a signal made up of a specific audiblesignal and visual signal alert the user that intubation can beattempted.

In some embodiments, as discussed further herein, when preoxygenation isinitiated, the medical device 202 may start a timer, pre-configurablefor example between 2-10 minutes (e.g., 3-8 minutes, 3-5 minutes, etc.),that provides for a minimum amount of time during which preoxygenationshould occur. That is, the rescuer should continue to givepreoxygenation ventilation until the timer expires, and then move on tothe subsequent step. The medical device 202 may detect thatpreoxygenation is occurring, for example, via a detected rise in oxygensensed by an oxygen sensor placed in the path of the patient airway. Asoxygen makes up about 21% of ambient air, when oxygen is given to thepatient, the percent of detectable oxygen in the airway may rise up to50% or greater (e.g., up to 60%, up to 70%, up to 80%, up to 90%, orgreater). As the difference between the inhaled and exhaled oxygendecreases along with flow associated with manual ventilations, themedical device 202 may make a determination that preoxygenation hasstarted. An associated rise in SpO2 (although delayed due tophysiological processes) may provide further confirmation that oxygen isbeing administered. Once it is determined that preoxygenation isoccurring, in certain embodiments, the preoxygenation timer discussedabove may be initiated.

In one embodiment of the present system, a step 310 is implemented; inthis step a determination is made of whether the patient is obtunded(i.e., unconscious). If the patient is not obtunded (i.e., conscious),then pretreatment and paralysis is performed in step 312. If the patientis obtunded, then there is no need for the sedation and paralysis stepbecause the patient is already unconscious. In an alternative embodimentof the present system, there is no determination of whether the patientis obtunded. Regardless of the patient's consciousness, the rescuers104, 106 immediately move to the sedation and paralysis of step 312. Thebenefit of skipping the obtunded patient analysis is that the drugs arefast acting and there is minimal additional risk in administering themregardless of the level of consciousness of the patient. Put anotherway, there are few situations in which the rescuers would not administerthe drugs, so it far more efficient and safer to administer the drugsand begin the intubation procedure than it is to spend time determiningthe level of consciousness of a patient with acute respiratory failure.

Practically speaking, the medical device may collect information thatwill assist in making a determination of whether the patient isobtunded, for example, via cameras affixed to the device; however, therescuer is typically in a better position to make that assessment.Accordingly, in some embodiments, the medical device may provide aprompt that reminds the rescuer to assess whether the patient isobtunded, so as to administer a suitable sedation treatment. Such aprompt may be given (e.g., as a display on the device screen, or audibleprompt) only for a period of time, and then the medical device may moveon to the next step, or the prompt may remain until a user provides aninput to proceed to the next step in the overall process.

In general, the pre-treatment (e.g., sedation) and paralysis of thepatient is to prevent issues with the tube placement (i.e., make thepatient tolerate or compliant with the procedure). For example, gaggingor vomiting can occur if the patient is conscious during the tubeplacement, which can significantly disrupt progress in tube placement.The patient is positioned in step 314. Generally, a preferred positionis the “sniffing” position, which is commonly used during laryngoscopy.In general, the “sniffing” position requires flexion of the neck,extension of the head on the neck, and the ear canal to be aligned withthe suprasternal notch. In addition, the medical device 202 may providespecific guidance for obese patients whose anatomy may require amodified position to optimize visualization of the airway and passage ofthe endotracheal tube where the traditional head-back “sniff” positionmay not be optimal. For example, the medical device includes the RapidAirway Management Positioner (RAMP) provided by Patient PositioningSystems of Eugene Oreg., for use with obese patients. Such a deviceprovides pneumatic control in safely raising or lowering the patient'sbody.

Prior to attempting intubation, the medical device may instruct (e.g.,via visual and/or audible prompt) the user to check and/or clear theairway of bodily fluids (e.g., blood, vomitus and secretions) that couldobscure the view of the airway and vocal cords in step 315. In addition,the medical device can detect the pause in ventilation while the rescuerchecks the airway and in another embodiment the medical device wouldreceive a signal from the medical aspirator that is used to performoropharyngeal suctioning to clear bodily fluids from the airway.Following the procedure, the medical device 202, via the airwaysensor(s), would detect the resumption of ventilation (e.g., viadetectable presence of gas flow) and automatically reevaluate thepreoxygenation criteria and indicate to the user the patient's readinessfor intubation. In one example, the medical device identifies the pausebased on the change in sensor data (e.g., ETCO2 waveform disappears) aswell as the programing of the medical device which “knows” and “expects”that the rescuers will need to fluid checks, thus the temporary andbrief change in data during preoxygenation is expected.

In step 316, preoxygenation is completed and a procedure timer may beinitiated in response to the completion of preoxygenation (e.g.,completion of preoxygenation may be based on an analysis of data frompulse oximeter 212, capnography sensor 218, and airway flow and pressuresensor (flow sensor) 221 in the airway sensor(s) 127). Such a proceduretimer may be a subsequent timer to that initiated during thepreoxygenation step. Once preoxygenation has been completed, the oxygenreservoir begins to be depleted once ventilation stops and so there is arelatively short window of time in which the intubation procedure mustbe completed to ensure that the patient is not dangerously deprived ofO2. In step 318, the rescuers (or caregiver) begins the endotrachealtube (ETT) placement. Accordingly, this step 318 during ET tubeplacement should happen expeditiously before the oxygen reservoir iseffectively exhausted.

Simultaneously, the medical device 202 monitors the procedure timer instep 322 and the O2 saturation levels in the patient in step 320 todetermine if the patient hypoxemic (e.g., O2 saturation level is below85-88%). If the procedure timer expires in step 322, then the medicaldevice 202 activates an alarm and displays a warning message in step 324indicating that the intubation attempt exceeded clinical norms. Thewarning may further include audible alarms such as sirens, tones, orvoice commands indication that the procedure timer has expired. Thealarm may further provide haptic feedback to the rescuer, e.g., viawrist-worn and/or heads up display devices. At this point, the rescuerperforming intubation must make a decision whether to abort theprocedure and manually ventilate and oxygenate the patient 102, asprovided in step 308 or, assuming the procedure is nearly complete,override or disregard the warning and complete and verify theendotracheal tube placement in step 326. Following a failed intubationattempt the medical device 202 may prompt the rescuer to reassessmultiple criteria to optimize the probability of success on their nextattempt in steps 325 and 323. Returning to step 320, if the O2saturation falls below a threshold (e.g., 85-88%, 85-93%, 88-93%,88-91%, or some other configurable amount) or exhibits a rapid decreaseand/or if an indicator of oxygen reserve (e.g., oxygen reserve index)falls below a threshold (e.g., 10-50%, 10-30%) or exhibits a rapiddecrease, then the rescuers must make a decision, as before, whether toabort the procedure and manually ventilate and oxygenate the patient 102in step 308 or override the warning and complete and verify theendotracheal tube placement in step 326. Following the standard of care,the medical device 202 may be configured to allow for three (3)intubation attempts before prompting the user to use an alternativesupraglottic airway as an alternative to an ETT. In various embodiments,the medical device 202 may count the number of attempts of intubationthat has occurred and provide an indication for how many intubationattempts have occurred. The medical device 202 may detect that therescuer has gone back to step 308, for example, by sensing that the BVMis being used for manual ventilations (e.g., accelerometers on the BVM,air flow from a flow sensor, oxygen detection by oxygen sensor inpatient airway). Additionally, a separate dashboard (not shown) may bepresented for a patient that required multiple intubation attempts. Inthis situation, the medical device 202 provides additional feedback andprompts to the user regarding patients that are difficult to intubate.For example, alternative head positions, different tube sizes, orseeking assistance of a more experience rescuer.

In the case of either a successful intubation or a failed attempt, themedical device 202, via the airway sensor(s) detects the return ofventilation using the flow signal. For a successful intubation, theairway sensor(s) detects removal of mask from the module and thenfollows the procedure described below to verify endotracheal tubeplacement. A failed attempt is indicated by the presence of the maskwhereby the medical device 202 prompts the user to reassess thesituation, 325, (e.g., patient position, additional clearing of theairway, a change in rescuer, etc.) while at the same time ensuringpreoxygenation and ventilation are occurring based on the airway flowsignal.

In the next step 328, post intubation monitoring is performed to ensurethat, for example, the tube was placed in the patient's airways, and notin their esophagus. This step 328 may include active monitoring of theintubation parameters (e.g., patient vital signs, graphical trends ofvitals, SpO2, ETCO2, heart rate, respiratory rate, ECG, etc.). Lastly,in step 330, the medical device 202 gathers and presents information fora post-case debriefing to allow the rescuers to record and/or reviewinformation related to the procedure, e.g., prompting the user to recordthe depth of the ETT placement as well as other relevant informationassociated with the procedure.

FIG. 3B is a flow chart illustrating steps performed during an emergencyintubation that involves less steps than the protocol shown in FIG. 3A,in accordance with an embodiment.

As detailed above, there may be some scenarios in which rescuers need toskip one or more step of during rapid sequence intubation and perform anintubation more quickly without all of the steps of the RSI.Accordingly, the rescuer may choose to bypass certain steps that he/shedeems to be unnecessary in view of the urgency of the situation. Suchsteps may be bypassed by rescuer input into the medical device and, insome cases, the decision(s) may be recorded by the medical device forintegration into the patient care record. In the first step 350, therescuer maintains oxygen supply, such as with a BVM or using theportable ventilator (e.g., provided to the patient via a sealed mask,nasal cannula, or other method). In the next step 352, the rescuerpositions the patient for intubation. As detailed previously, this mayinclude positioning the patient in the “sniffing” position, whichrequires flexion of the neck, extension of the head on the neck, and theear canal to be aligned with the suprasternal notch. Next, the medicaldevice 202 may instruct (e.g., via visual and/or audible prompt) therescuer to check and/or clear the airway of bodily fluids (e.g., blood,vomitus and secretions) that could obscure the view of the airway andvocal cords in step 354.

In the next step 356, the rescuer begins the endotracheal ET tubeplacement. As before with rapid sequence intubation, this procedureshould happen expeditiously as the patient's oxygen reservoir may beeffectively exhausted or the patient may already have undergone someamount of time without oxygen.

In the next step 358, the medical device 202 determines whether tubeplacement was successful. Typically, this verification is accomplishedby measuring one or more physiological parameters (e.g., presence of CO2waveform, sufficient change in transthoracic impedance) of the patientalong with auscultation of the patient at different sites. Possiblemethods for verifying tube placement are described in detail below withrespect to FIGS. 15A-15G, although other methods are possible.

If the tube placement was successful, then the medical device 202 maymove into post-intubation monitoring in step 360. During post-intubationmonitoring, the medical device 202 may perform regular checks to confirmthat the ET tube remains properly placed. For example, the device maymeasure one or more physiological parameters similar to that used duringthe initial ET tube placement at regular intervals to ensure that the ETtube does not become dislodged. Additionally, a post-case debrief can beperformed in step 362 as well, where recorded parameters, waveforms, andother information associated with the medical event are made accessiblefor review. As detailed before, step 360 may include active monitoringof certain intubation parameters (e.g., patient vital signs, graphicaltrends of vitals, air flow in the patient's airway, SpO2, ETCO2, heartrate, respiratory rate, ECG, etc.) via the display on the medical deviceand/or on the portable computing device 225. Similarly, the post-casedebriefing of step 362 allows the rescuers to record and/or reviewinformation related to the procedure.

Returning to step 364, if the tube placement was not successful, thenthe medical device 202 may determine if a certain number of attemptsexceeding a threshold (e.g., three or more attempts) have been made atintubation in step 364. If a number of attempts exceeding the thresholdhave been made, then the medical device 202 provides an indication oralert to seek an alternative remedy (e.g., a tracheotomy, other courseof action) in step 368. The attempts may include attempts made frommultiple users, or possibly only attempts made by a single user (e.g.,most senior rescuer, specialist).

If a number of attempts less than the threshold have occurred, then thesystem determines whether drugs (e.g., paralytics) have been provided instep 366. If the drugs have previously been administered, then themedical device 202 reverts back to step 356 to initiate another attemptat endotracheal tube placement. While not illustrated, the medicaldevice 202 may display an attempt counter and/or other messageindicating whether to continue with another attempt.

If drugs have not been previously administered, then the medical device202 may provide an indication, such as a reminder or suggestion, toprovide drugs (e.g., paralytics) in step 370. It should be noted thatthe drug administration may or may not be needed. Likewise, they may ormay not even be available. As such, the final decision to provide thedrugs is made by qualified medical personnel. In certain embodiments,the medical device 202 may provide a reminder or suggestion toadminister an appropriate drug, for example, according to a defaultprotocol, and the caregiver may follow or ignore thesuggestion/reminder. Such a suggestion or reminder may remain on thedisplay of the medical device, may disappear after a certain timeperiod, or remain disappear when the medical device receives an inputfor the suggestion or reminder to be removed. As further detailed below,the medical device 202 may provide dosage information, for example,based on the actual height or weight, and/or ideal body weight of thepatient (depending on the medication and dosage requirements).

FIG. 4A is an exemplary user interface of the medical device 202. In theillustrated embodiment, the medical device 202 includes a display 504for displaying patient information in a graphical user interface.

The graphical user interface presents relevant information to rescuersconcerning the patient. For example, window 506 displays noninvasiveblood pressure (NIBP) including systolic and diastolic values, window508 displays peripheral oxyhemoglobin saturation (SpO2) and window 510displays the patient's heart rate in beats per minute (BPM).

The display 504 further includes the ability to displayelectrocardiogram (ECG) waveforms and end-tidal carbon dioxide (ETCO2),which is the maximal partial pressure of CO2 at the end of an exhaledbreath of the patient. As discussed further below, trending of patientvitals may also be provided by the medical device.

Additionally, the illustrated embodiment of the medical device 202includes a series of soft keys 516-526 and associated display windows515. The medical device 202 further include arrow keys 530, 534, and aselect button that enables a user to scroll and select options presentedin the interface. In the illustrated embodiment, the soft keys areprogrammed to enable a user to select between different “dashboards,”for assisting the user in diagnosing and ultimately carrying out themost effective treatment for the patient. Each dashboard may be selecteddepending on the particular situation at hand, and may displayinformation relevant to that situation. Such dashboards include, forexample, cardiac distress, altered mental status, respiratory distress,traumatic brain injury, or other settings based on a library of patientconditions and associated dashboards. Pressing any of the soft keys willoverride the medical device 202, and immediately take the rescuers tothe desired dashboard for assisting the rescuer facing that particularpatient situation. The graphical user interface and the informationpresented to the user would change based on which dashboard is selected,an example of the dashboard suitable for treating a patient who hassuffered from traumatic brain injury is provided below in FIG. 4B.Similarly, to the above, selection of an airway management dashboard,e.g., via selection 524, also accessible from one or more of the otherdashboards, may immediately bring the medical device into the processflow generally provided by FIG. 3 and further discussed herein. In somecases, the medical device may be in a particular dashboard mode, and ifa determination is made that the patient is in need of intubation, themedical device may then proceed down the airway management pathway, ormay provide a suggestion on the user interface for the user to confirmto move forward with the intubation procedure.

In an alternative embodiment, the medical device 202 utilizes a touchscreen display rather than soft keys. In this embodiment, all, or nearlyall of the front face of the medical device is a touch screen displaydevice and the soft keys are removed. In yet another embodiment, themedical device 202 includes one or more dials that enable the rescuersto change dashboards, functionality of the medical device (e.g., set themedical device to be in defibrillator mode, monitor mode, ventilationmode, CPR mode), make selections, or change which information isdisplayed.

FIG. 4B is a screenshot of a non-limiting, current implementation of atraumatic brain injury (TBI) dashboard 550 that would be displayed inresponse to a rescuer selecting the TBI dashboard soft key 522. In thisparticular example, the TBI dashboard 550 includes a ventilation timerand status bar that provides an indication of when to ventilate next.Other ventilation parameters for providing ventilation feedback to therescuer who is providing manual ventilation may be provided, such astidal volume of each positive pressure breath and the rate ofventilations (e.g., in breaths per minute).

Additionally, the TBI dashboard 550 further displays trends such as theSpO2 trend 554 of the patient 102, a NIBP trend 556, and ETCO2 558.Trends are useful in helping to determine and/or predict the patient'sclinical progression. For example, patients' oxygen saturation willrarely drop from normal levels to hypoxemic levels instantly. Rather,there is typically a trend of falling oxygen saturation (desaturation),which is an indication that patient may soon be in danger. If the deviceis only monitoring or displaying “instant” oxygen saturation levelsand/or only analyzing whether the patient is above a predefinedthreshold (e.g., 88 to 94%), then the device will not generate an alarmuntil after the patient has fallen below the threshold. Thus, it isbeneficial to monitor trends, in addition to “instant” oxygen saturationlevels to enable the medical device 202 to identify developing issue andallow the rescuers to intervene prior the dangerous situation (e.g.,reinitiate manual ventilation). Obviously, identifying similar trendswith respect to heart rate, ETCO2, and blood pressure would also bebeneficial for similar reasons, for example, as compared to baseline orprevious vital sign values. In addition to displaying sensor data themedical device 202 may also use changes in the audible tone and/orfrequency to indicate changes in the physiologic parameters or airwaygas parameters. This allows rescuers to maintain their focus on thepatient while alerting them to changes in the patient's condition.

While the reference numerals have been omitted for clarity of thefigure, the embodiment of FIG. 4B includes (e.g.) windows displayingoxygen saturation, noninvasive blood pressure (NIBP), heartrate, asdetailed in FIG. 4A.

FIG. 4C is an exemplary alternative user interface (dashboard) of amedical device for treating a traumatic brain injury (TBI) patient inaccordance with another embodiment. This dashboard illustrates theflexibility of the dashboard and a possible alternative display, showingrelevant parameters, for example, trending ETCO2, trending bloodpressure readings, trending SpO2 values, and ventilation feedback.

With reference back to step 302 of FIG. 3, FIG. 5 is a flow chartillustrating steps performed during a determination of whether a patientneeds rapid sequence intubation in accordance with various embodiments.

In the first step 402, the rescuer encounters the patient and determinesif the patient is breathing. This step is essentially a differentialdiagnosis performed by the rescuer to determine whether the patientneeds CPR chest compressions, ventilations, defibrillations, or someother appropriate emergency treatment. If the patient is not breathing,then in step 403 the medical device may optionally indicate thatassisted ventilation and/or oxygenation is required and the rescuersventilate the patient in step 405. Or, once the rescuer determines thatventilations are required and subsequently administers positive pressurebreaths, the medical device may detect that ventilations are being given(e.g., via an air flow sensor positioned in the patient airway,optionally included along with the BVM and/or airway sensor(s)). In step404, the medical device prompts the rescuer to attach sensors (e.g., oneor more of sensors 210-221) to the patient 102, so as to becommunicatively coupled with the medical device 202. The medical device202 then receives and analyzes the intubation parameters obtained fromthe sensors (e.g., physiologic, non-physiologic, airway gasmeasurements) in steps 406 and 408, respectively. In certainembodiments, once the medical device receives data from the one or moresensors attached to the patient, the medical device then advances to thenext step in determining whether there is need for intubation.

As the medical device is receiving and analyzing the patient data, themedical device 202 may also optionally display a prompt reminding therescuer to check the patient's airway in step 410. In addition to theprompt to check the patient's airway, the medical device 202 may furtherprovide a prompt for the rescuer to suction/clear the airway if needed.Such a prompt may be a reminder for the rescuer to check whether theairway needs to be suctioned or cleared, to prevent aspiration andfacilitate intubation.

In step 412, the medical device 202 determines if the patient 102requires intubation. In general, the determination whether the patientrequires intubation may be a determination of whether the patient hassome form of acute respiratory failure (e.g., lack of breathing, apnea,gasping, labored or agonal breathing, etc.) or some other condition thatcould affect the patency of the airway (e.g. facial trauma or burns). Inone implementation, this is done by initially placing the BVM, which mayinclude one or more of the airway sensor(s), over the patient's mouthand attaching a pulse oximeter 212 to the patient 102. Based on themeasured sensor data, the medical device 202 automatically analyzes thepatient breathing (or lack thereof) and oxygen saturation to determineif measured the overall combination of sensor data (e.g., inspiratoryflow, expiratory flow, ETCO2 waveform, oxygen saturation) are indicativeof acute respiratory failure. Accordingly, depending on data collectedfrom the sensor(s) associated with the medical device 202 (e.g., one ormore of ETCO2, oxygen saturation, flow rate), the medical device maymake a determination of whether intubation of the patient is needed and,hence, may provide a suggestion for the rescuer to consider movingforward with the intubation process. For example, an ETCO2 value greaterthan 50 mm Hg (millimeters of mercury) coupled with an oxygen saturationlevel below 85 to 88% may be indicative of acute respiratory failure.Additionally, the medical device 202 may further analyze the flow rateof gas within the patient airway to determine whether pattern is regularand tidal volume and respiratory rate are able to provide for adequateventilation or are indicative acute respiratory failure. In variousembodiments, the medical device 202 may compare airway gas measurementsin the patient airway to the recommended flow volume for the patientheight, weight and gender had been met (e.g., an adult male should haveinspiratory/expiratory flow volumes of about 400 mL), which may informthe determination by the medical device 202 of whether the patientrequires intubation. Or, rather than an automatic determination, arescuer may simply provide an input into the medical device 202 thatintubation is required, and the relevant information and promptings maybe activated.

If the medical device 202 determines that the patient does not requireintubation, then the medical devices returns to the main dashboard,e.g., the graphical user interface shown in FIG. 4 that guides therescuers 104, 106 management and monitoring of the patient in step 414.If the medical device 202 determines that the patient does needintubation, then medical device may prompt or provide a recommendationto the user for intubation and/or may automatically advance to the nextstep in the procedure. This is in response to changes in sensor dataand/or actions being performed by the rescuers which are indicative thatthe rescuer has initiated the next step in the intubation procedure instep 416.

FIGS. 6A and 6B are exemplary user interfaces (or dashboards) of themedical device 202 displayed during the determination of whether thepatient needs rapid sequence intubation.

As shown in the illustrated example and described with respect to thesteps in FIG. 5, the medical device 202 displays prompts or reminders tothe rescuers prior to, during, and after the intubation procedure. Inthe illustrated figures, a message box 528 prominently displays promptsand/or reminders to the rescuers 104, 106 (e.g., to check patientairways, section airways to remove bodily fluids/secretions, and toattach sensors and ECG leads). Additionally, the soft keys and theirassociated text and/or touchscreen inputs identify which step iscurrently being performed by highlighting the current step in theintubation procedure. Additionally, the text displays which steps arenext in the procedure (slowing the rescuers to override the procedure asthe medical situation dictates).

In an alternative embodiment, the medical device 202 prompts therescuers 104, 106 and requires the rescuers 104, 106 to confirmcompletion of the steps in order to advance the medical device to thenext step in the procedure. This is to ensure the medical device doesnot inadvertently move to a new step before the rescuers have completedthe current step. For example, after preoxygenation has been completedand the rescuers begin tube placement, the ETCO2 waveform will change(and possibly disappear) as the patient is no longer receiving manualventilations and/or oxygen. If, however, there was a sensor failure (orother incorrect sensor reading), the medical device 202 may beconfigured to automatically move to the next step in response to thechanged sensor reading, which appears to indicate that preoxygenationwas stopped by the rescuers. By including prompts and requiring therescuers to confirm the completion of the steps, any potential harm fromfalse positives is eliminated.

FIG. 7 is a flow chart illustrating typical steps performed whilepreparing the patient 102 for a rapid sequence intubation procedure inaccordance with embodiments discussed herein.

In the first step 602, the plurality of sensors (e.g. sensors 210-221),for example of the medical device 202 obtain the patient data (e.g.,physiologic, non-physiologic, airway gas measurements) and transmit theobtained data to the medical device 202 to be displayed on the screen ofthe display 504. Some examples of information provided to the medicaldevice may include NIBP, SpO2, ETCO2, heart rate, respiratory rate, andtidal volume. Next, in step 604 the medical device 202 may display thereceived patient data in the display 504.

The medical device 202 may determine if there was a sensor fault (e.g.,sensors need adjustment) in step 606. If the sensors need adjustment,then (e.g.) the sensor is adjusted (or replaced) depending on the fault.In any case a context-sensitive alarm is triggered alerting the user tothe fault or failure while providing instructions to resolve or mitigatethe fault or failure. However, if the sensors do not need adjustment,then the medical device 202 prompts the rescuers to enter patientinformation, such as height, weight, age, and gender in step 610. Thispatient information is beneficial because a number of calculations maybe determined based on the patient's information. For instance, thedosage of drugs required may differ based on patient information (e.g.,larger patients may require larger drug dosages than smaller patients).Or, the appropriate ET tube size may be different for different types ofpatients (e.g., a child may require a smaller ET tube as compared to anadult).

Next, in step 612, the medical device 202 identifies the tube andlaryngoscope size based on the entered information from step 610.Alternatively, the rescuers may make the determination of the tube orlaryngoscope scope size based on their own assessment of the patient102, which may or may not differ from the tube or scope size recommendedby the medical device.

Next, based on the patient's height, weight, age, and gender, themedical device 202 may calculate and display the recommended drug dosagein step 614. Commonly used drugs include: Etomidate, Fentanyl, Ketamine,Midazolam, Propofol, Succinylcholine and Thiopental. For example, atypical dosage for Etomidate may be 0.3-0.4 mg/kg. In variousembodiments, the drug dosage calculation based on entered patientinformation may be pre-configured by a medical professional. Preferably,the rescuers would follow the recommendations of the medical device 202whose programing reflects the process defined by the local ororganizational medical guidance, but the rescuers are always able tooverride the recommendations of the medical device.

Next, in step 616, the medical device 202 calculates and displaysindicate the preferred pattern of ventilation, breathing rate and tidalvolume, for the patient 102 based on the entered patient information andbest practice information stored in the memory 209 of the medicaldevice. These ventilation parameters may be used by the medical device202 to provide feedback to the rescuer during manual ventilation, sothat the rescuer is better able to provide ventilation at a rate andtidal volume appropriate for the patient. Lastly, in step 618, themedical device 202 monitors and displays BVM performance information inthe display of the medical device 202 in step 618. For example, themedical device 202 monitors for deviations from the prescribed patterns(e.g., waveform), rate (e.g., breaths per minute) and tidal volume(e.g., mL). An alarm or other feedback may be triggered to alert orotherwise better guide the user in the event the prescribed pattern ofventilation is not followed or if other conditions (e.g., mask leak orhigh airway pressure), which could affect patient safety, are detected.

FIGS. 8A and 8B are exemplary dashboards (e.g., user interfaces)displayed on the medical device 202 during the preparation of thepatient for rapid sequence intubation.

FIG. 8A illustrates an exemplary ventilation dashboard 570, whichincludes an animated indication of ventilation 572, which providesreal-time feedback to the user regarding their performance with the BVM.In the illustrated example, the indicator 572 is a circle, which fillsas the ventilation bag 112 is squeezed to deliver a breath to thepatient. If the rescuers are delivering the appropriate tidal volume,then the entire circle fills. If the delivered tidal volume is less thanthe target volume, then only part of the circle fills. And if therescuers deliver an excessive tidal volume, then the circle fillscomplete, and gives a notification that an excessive tidal volume hasbeen delivered (e.g., possible over-filling, color change, warningmessage of excessive volume). Additionally, the color of the circle maychange from, e.g., green to red or yellow when the user is notventilating at the proper breathing rate. An animated timer 573 providesa countdown indication for when to deliver the next ventilation.Additionally, a volume indicator 576 displays the desired and/or actualtidal volume delivered (in this particular example, the desired tidalvolume is preconfigured and the actual tidal volume delivered isdisplayed). Similarly, the ventilation tracker 578 shows when breathswere delivered and their respective tidal volume in bar graph form. Inthe illustrated example, the ventilation tracker 578 is shown in placeof the ETCO2 waveform; however, in alternative embodiment, theventilation tracker 578 and the ETCO2 waveform may be shown at the sametime concurrently.

The dashboard 570 further displays desired and/or actual rate ofventilation 574, which display the number of breaths per minute thatrescuers should deliver to the patient. In this particular example, thedesired rate of ventilation is preconfigured and the actual ventilationrate is displayed.

While not expressly shown in the figures, for patients that areundergoing agonal breathing and may benefit from assisted ventilation,the ventilation feedback may provide cues for the rescuer to providesuch assistance. For instance, data from the sensor(s) may provide someindication that the patient is breathing (e.g., flow sensor may detectpositive or negative pressure arising from the patient), and so may thenprovide a cue (e.g., audible, visual, haptic) for the rescuer toimmediately initiate a positive pressure breath in support of thepatient's effort.

FIG. 8A further illustrates an example of how the medical device 202 isable to suggest an endotracheal tube (ETT) size based on, e.g., thepatient's information (e.g., height, weight, age and gender). Ingeneral, there are many different standard tube sizes. Which size tubeis required or preferred, is generally based on the patient'sinformation. Illustrated by way of example, in younger children, thetypical diameter for children (in millimeters) is calculated as: (age inyears/4)+4; and the depth of the tube is calculated as: (age inyears/2)+12. Thus, a 4 year-old will need a tube that is (4/4)+4 or 5 mmin diameter and 5/2+12 or 14.5 cm, which rounded down to 14 cm.Teenagers and adults typically have less variations, but still have somevariations. For example, a teenage male might require the same size anadult female (e.g., a 6.5 mm (diameter) by 18 mm (depth)). Whereas, anadult male (or large teenage) might need an 8 mm depth by 21 mm (depth)tube, for example. Additionally, the patient's information could also beused to recommend the size of an alternative airway, e.g. for alaryngeal mask. For ventilation parameters (e.g. rate, tidal volume) themedical device 202 uses the adult patient's height (centimeters orinches) and sex to determine the required tidal volume and idealrespiratory minute volume which is then divided by tidal volume todetermine the respiratory rate.

In the illustrated embodiment, once the patient information is entered,the suggestion tube size is subsequently presented in message box 528.In an alternative embodiment, the information may be provided audiblyand/or broadcast to the alternate interface devices (e.g., wrist-worndevices 120, 122 or wearable heads-up display devices).

FIG. 8B further illustrates how the medical device 202 is able tosuggest dosage information based on the patient's height, weight, ageand gender. As before, upon receiving the patient information, thesuggested dosage may be presented in message box 528 in the display 504of the medical device 202. The information may be presented as thespecific dosage amount (e.g., 30 mg based on a 100 kg patient based onguidance of 0.3 mg/kg to be administered) or may provide the dosageranges. Additionally, some medication dosages are based on the patient'sactual weight (i.e., current measured or estimated weight), or theirideal body weight, which is function of their height and gender.Similarly, other treatment aspects such as breath volume are dependenton ideal body weight. In one example, the patient measured weight couldbe obtained from an electronic litter (or gurney) that is capable ofmeasuring the height and weight of the patient on the device. Thesedevices may then communicate wirelessly to the medical device 202 orportable computing device 225.

While the reference numerals have been omitted for clarity, theembodiments of FIGS. 8A and 8B include windows displaying ECG, oxygensaturation, NIBP, heart rate, respiratory rate, temperature, as detailedwith respect to FIG. 4A.

FIG. 9 is a flow chart illustrating typical steps performed during thepreoxygenation of the patient 102 during a rapid sequence intubationprocedure in accordance with embodiments presented herein.

In the first step 802, rescuers provide oxygen to the patient via manualventilation. As discussed above, the medical device 202 may providemanual ventilation feedback so that the rescuer is more likely to staywithin the desired range of ventilation rate and tidal volume. Next, instep 804, the medical device 202 initializes a preoxygenation timer.This preoxygenation timer is based on a recommendation that patientsshould be preoxygenated for at least three (3) minutes prior tointubation to ensure that the patients have enough oxygen “stored” intheir body during the intubation procedure. In addition, the duration ofpreoxygenation can be modified based on data from the O2 sensor(s)positioned in the patient airway and/or based on the rate at which thepatient's lung denitrogenates and becomes a fully saturated anatomicalO2 reservoir. In various embodiments, the timer is started automaticallyin response to one or more of the sensors (e.g., the O2 sensor 210,capnography 218, or flow sensor 221) indicating that ventilation and/oroxygenation is being delivered to the patient 102. For instance, oncethe oxygen sensor (e.g., provided with the airflow sensor module and/orBVM) senses an appreciable increase or acceptable amount of oxygenpresent in the patient airway, then the medical device 202 may make adetermination that preoxygenation has begun and, hence, may start thepreoxygenation timer as a reminder to the rescuer that ventilationsshould be given at least for the allotted period of time. That is, themedical device 202 may remind the rescuer to continue giving manualventilations until the timer has expired. In step 806, the O2 sensorpositioned in the patient airway measures relevant data, such as oxygenamount or concentration in the air flowing in the airway and then instep 808 the data is transmitted to the medical device 202 and displayedand/or transmitted as described above. As noted above, since oxygenmakes up about 21% of ambient air, during preoxygenation, the percent ofoxygen in the exhaled gas will increase (e.g., 50% or greater, up to60%, up to 70%, up to 80%, up to 90%, or greater). The rate of flowdetected in the patient airway may also be a positive indication for themedical device 202 to determine that preoxygenation is occurring. Hence,the medical device 202 may use oxygen detection and/or flow rate asindicators of the step of preoxygenation. Similar to the dashboard shownin FIG. 4B or 4C, the medical device 202 may display trendinginformation for SpO2, NIBP, ETCO2 and/or other relevant data in thisstep in the procedure. During preoxygenation, it may be helpful forpatient vitals such as oxygen saturation (e.g., SpO2) to be prominentlydisplayed so that it can be confirmed that the level of oxygensaturation of the patient is increasing or otherwise remaining at anacceptable level. In related embodiments, the medical device 202 wouldpresent a composite, based on an aggregated calculation of thephysiologic signals, to present a preoxygenation index that indicatesthe extent to which the patient is preoxygenated. This index could use avalue-based indication or a quantized scale (e.g. red, yellow, green) toguide the rescuer as to when intubation should be attempted.

In step 810, the pulse oximeter 212 of the medical device 202 monitorsthe SpO2 of the patient and determines if the value is below a threshold(e.g., levels associated with hypoxemia, such as below 88 to 92%).Alternative embodiments monitor trend of oxygen saturation, ETCO2, andNIBP, to list a few examples. If the SpO2 is below a set thresholdlevel, then the medical device 202 may activate an alarm in step 812. Ifthe SpO2 remains above the set threshold (i.e., not hypoxemic), then themedical device 202 may further determine whether a leakage is detectedin step 818. If a leakage is detected in step 818, then an alarm isactivated and a warning message is displayed in step 820 that a leakageis present included instructions on how to resolve the leakage.

If leakage is not detected, then the medical device 202 determines ifthe preoxygenation timer is greater than zero in step 822. While theleakage detection step is shown as step 818, in a typicalimplementation, leakage detection may be implemented anytime the patient102 is connected to a device delivering ventilation and/or oxygen (e.g.,BVM or ventilator). In general, leakage may be detected by analyzing theinspiratory and expiratory flow patterns or rates, and pressure signalsby the flow sensor 221. Ideally, the inspiratory and expiratory tidalvolumes should be approximately equal. If the expiratory tidal volume issignificantly smaller than the inspiratory (e.g., 400 mL inspiratory andonly 150 mL expiratory), then the medical device 202 may determine thata leak is present and trigger and alarm with mitigation instructions.

If the preoxygenation timer is not greater than zero (i.e., timerexpired), then the medical device 202 may activate an alarm in step 826indicating that the preoxygenation timer has expired. This time is ageneral reminder or guideline to ensure that patient is preoxygenatedfor at least three minutes. Depending on the patient condition,saturation levels or breathing pattern, preoxygenation may take longer.In one embodiment, the timer automatically readjusts based on measuredoxygen saturation values and acts as more of a prediction of how longuntil hyperoxygenation has been achieved. In some embodiments, while notexpressly shown in the figure, once the timer has expired, the medicaldevice 202 may make a determination of whether a suitable level ofhyperoxygenation has been achieved, as discussed below.

If the preoxygenation timer is greater than zero, then the medicaldevice 202 may make a determination of whether hyperoxygenation and/ordenitrogenation hyperoxygenation in the patient 102 is achieved in step824. This may be determined based on signals measured by the airwaysensor(s). In general, air is comprised of (about) 21% oxygen and 79%nitrogen (and some other trace gases). Thus, unenriched ventilation withair does not maximize the lung's ability to store oxygen. The goal ofpreoxygenation is to replace as much nitrogen from the patient withoxygen and create an oxygen reserve, for supplying oxygen to the patientduring the apneic/nonventilated period during endotracheal tubeplacement. In a preferred embodiment, in which the BVM or ventilator isdelivering enriched oxygen, the airway management system is verifying,e.g., that the inspiratory flow is 100% oxygen and the expiratory flowis, e.g., ˜90% oxygen (i.e., the vast majority of expelled gas isoxygen, which indicates the oxygen reserve is full). If the patient isnot expelling greater than 90% oxygen, for example, then the patient isdetermined to not be hyperoxygenated.

If the patient is sufficiently hyperoxygenated, then the medical device202 provides an indication that patient is hyperoxygenated and may thenmove to next step in intubation procedure in step 828. If the patient isnot hyperoxygenated, then the medical device 202 may return to step 806to continue measuring ventilation and O2 delivery to the patient. Whilethe illustrated embodiment of steps FIG. 9 is illustrated as a series ofsequential steps, the medical device 202 typically is monitoring, e.g.,the SpO2, leakage, and the timer substantially simultaneously. Whenpreoxygenation is completed, the medical device 202 may initialize asubsequent procedure timer (discussed further below), which sets forth aperiod of time in which the ET tube should be properly positioned. Ifthe procedure timer expires and the ET tube is not properly placed, thenthe patient is at risk of desaturation due to depletion of the oxygenreservoir within the lungs of the patient.

FIG. 10A is an exemplary user interface displayed on the medical device202 during the preparation of the patient for rapid sequence intubation.The illustrated embodiment displays a preoxygenation timer 590 and anoxygen reserve indicator 592. Preoxygenation timer 590 provides anumerical timer and/or a visual indicator of how much time remains(e.g., the bar slowly drain in accordance with remaining time.Similarly, the oxygen reserve indicator (ORi) which provides anestimation of “how full” the patient oxygen reserve is. The oxygenreserve indicator may provide a numerical value and/or a progress bar594. As discussed above, this information may be based on expiratoryflow measured by the airway sensor(s) 221. Lastly, the dashboard mayinclude a leakage alarm 596, which will display a message in response tothe detected leak. Additionally, the medical device 202 may beprogrammed to provide distinctive audio tones upon, e.g., expiration ofthe preoxygenation timer 590 or fulfilling of the capacity determined byORi 592.

FIG. 10B is an additional exemplary user interface that may be displayedon the medical device 202 during the intubation procedure. In theillustrated example, the display 504 of the medical device 202 displaysan oxygen reserve indicator (ORi) 648, which is an intubation parameterthat provides information on the amount of oxygen reserve a patient hasduring the intubation procedure. Additionally, the medical device 202further provides a visual representation of SpO2 649. In one example,the ORi is a unit-less scale between 0.00 and 1.00 (where 1 is fulloxygen reserve and 0 is an empty reserve).

Each of the points represents a step (or event) that occurs duringintubation. For example, point 650 represents the point at which thepatient 102 begins receiving manual ventilation and oxygen. As shown inthe figure, the patient's SpO2 starts off around 95% and slowly beginsto climb toward 100%. Then, at point 651, the patient begins thepreoxygenation step and the oxygen reserve begins to fill. Point 652,shows the point at which preoxygenation was completed and oxygen reservebegins to deplete (e.g., the rescuers have begun the intubation processand are no longer providing ventilation). As illustrated, the declinegenerally starts slowly, and then begins to descend rapidly. Point 654represents when an alarm would be activated. As the oxygen reservedepletes, the SpO2 also begins to decline. Point 658 illustrates a pointat which the SpO2 begins to decline and Point 660 represents the pointat which an SpO2 threshold is passed (e.g., between 88 to 92%). Point661 represent a point at which the intubation should be completed (oraborted) and the rescuers 104, 106 began ventilating and providingoxygen to the patient to correct the hypoxemia. Lastly, point 662,represents the point at which the patient is back SpO2 is back to normallevels (e.g., approximately 94%).

An example of a device capable of measuring SpO2 and calculating theoxygen reserve index is the Radical 7, Rainbow SET (Signal ExtractionTechnology) by Masimo from Irvine, Calif.

FIG. 11 is a flow chart illustrating typical steps performed during thepretreatment (e.g., sedation) and paralysis of the patient 102 duringthe rapid sequence intubation procedure in accordance with embodimentsof the present disclosure.

In the first step 1102, the medical device 202 displays patient data inthe display 504. In the next step 1104, the medical device 202 displaysuser selectable event or code markers (e.g., sedatives, analgesics)based on relevance to the current step in the procedure. The codemarkers provide a record of which drugs were administered to the patientand the time, date and route of delivery. Once a relevant code marker isselected, this information is saved in the memory of the medical deviceand is retrievable for later analysis or documentation of the drugs andtreatments provided to the patient during the rescue. In certainembodiments, the rescuer may provide a manual input (e.g., voice input,touchscreen, keypad, buttons/softkeys, external computing device, etc.)to select the particular code marker. In other embodiments, the medicaldevice may be provided with an indication that a particular drug hasbeen administered, and so a code marker may be recorded. For example, asdiscussed below, the medical device may scan a bar code or detect anRFID associated with a particular drug to be administered and may logthe code marker at that time.

In an alternative embodiment, the rescuers may have considerableexperience and are extremely proficient in rapid sequence intubation. Inthis scenario, the rescuer may override suggestions provided by themedical device (e.g., via user input), and the rescuer may determinewhich drugs to administer to the patient 102 in step 1110. Similarly, instep 1112, the rescuer manually selects amount of drugs to deliver.

Returning to step 1106, the medical device 202 detects which (if any)drugs have been administered to the patient (e.g., via manual input, barcode scan to confirm the type and amount of drug for administration) andthe automatically stores a code marker (e.g., time administered, drugtype, and amount) to memory in step 1108. In one embodiment, eachsyringe includes a barcode or radio frequency identification (RFID)chip, for example and the medical device includes a correspondingbarcode reader. The rescuer(s) 104, 106 scan the syringe prior toadministration and the medical device stores a record of whichmedication was given along with a time and date stamp.

In step 1114, the medical device displays currently administered drugsand dosage(s) to enable the rescuer to view which drugs wereadministered. In the next step 1116, the medical device determines ifthe patient requires additional administrations of the drug. If thepatient requires additional administration of the drug, then the medicaldevice 202 initializes a timer in step 1120 to provide an indication tothe rescuer of when recurring medication needs to be administered. Ifthe patient does not require additional medications (e.g., the patientis properly sedated), then the medical device 202 moves to the next stepin the procedure in step 1118.

FIG. 12 is an exemplary user interface displayed on the medical deviceduring the preparation of the patient for rapid sequence intubation. Inthe illustrated example, code marker information associated with drugadministration is presented in message box 528. As detailed previously,the dosage information could be the specific amount (based on thepatient's height, weight and/or gender) or just the dosage range.

FIG. 13 is a flow chart illustrating typical steps performed during thepatient positioning steps of the rapid sequence intubation procedure inaccordance with embodiments presented herein.

First, in step 1302, the medical device 202 displays patient data in thedisplay 504. In the next step 1304, the medical device 202 displays aschematic of proper patient orientation and position to perform theintubation or an alternative based on the patient information, e.g.weight, height and sex. In the next step 1306, the medical device 202determines if the SpO2 is under the threshold (e.g., hypoxemia) or ifthe timer has expired. If the patient is hypoxemic or the proceduretimer has expired, then the medical device 202 activates an alarm anddisplays a warning on the display 504 in step 1314. In some embodiments,an alarm/notification may be provided before the patient becomeshypoxemic, e.g., when the SpO2 falls below a threshold (e.g., 90 to 92%)that is typically higher than that which would be considered hypoxemic,indicating that the patient is at risk of desaturation. The apneicperiod after preoxygenation, during intubation is particularly sensitivebecause the only source of oxygen for the patient's tissues is comingfrom the oxygen reservoir built up in the lungs. As a result, themedical device 202 times the apneic period and provides a time-basedalarm if the user exceeds the time prescribed by the local medicalguidance (e.g. 30 to 60 seconds). Similarly, in step 1308 the medicaldevice 202 detects if the patient's body or head movement has moved thepatient out of proper positioning. In one embodiment, the medical device202 includes one or more cameras (not shown) and implements imageanalysis processing to identify features (head, torso, arms) of thepatient to guide position of the body. In another embodiment, motionsensors are placed on the patient's torso and record patient movements(e.g., 12 ECG leads, which are placed on the patient's body may furtherinclude position sensors to measure relative positions and identify theposition of the patient).

In yet another alternative embodiment, the medical device 202 simplydisplays an image of proper position (e.g., the sniffing position) andhow to align the body, for the rescuer to compare proper positioningwith actual positioning of the body. Likewise, the medical device 202 isable to display a variety of images based on the previously enteredheight, weight, age and gender information. The images may be displayedfor a preset period of time, or until the rescuers indicate thatpositioning has been completed.

If the patient's head or body moves in a way that brings the patient outof a suitable position for intubation, then the medical device 202 mayactivate an alarm and display a warning in step 1314. Generally, afteran alarm, the rescuers 104, 106 will make a determination of whether tocontinue with the procedure (e.g., complete intubation) or whether toabort the procedure and, e.g., manually ventilate and oxygenate thepatient 102 in step 1316.

Lastly, in step 1310, the medical device 202 determines if the patient102 is in proper position to begin intubation, for example, viaimage/video information captured by cameras incorporated in or otherwiseassociated with the medical device, and/or motion or positioninginformation provided by motion sensors on the patient body.Alternatively, using data from the patient liter or stretcher thatprovides patient position information. If the patient 102 is in properposition (e.g. “sniffing” position or “RAMP” position), then the medicaldevice 202 continues to the next step in the intubation procedure instep 1312. If, the patient is not in proper position, then the medicaldevice 202 displays the warning from step 1314. In an alternativeembodiment, the medical device 202 may also be able to aid the rescuerin positioning. For example, the medical device 202 may be able toprovide visual or audible feedback to guide the position of the patientinto correct position for the intubation.

Typically, each warning is specific to the issue detected (e.g., SpO2,timer expired, head movement, etc.). Additionally, the medical device202 will typically provide suggestions for how to correct the issue,rather than presenting binary choices of aborting the procedure orcontinuing despite the warning.

Alternatively, in another embodiment, the warning is a general warningthat is not specific the identified issues. While the illustratedembodiment depicts the warning being displayed visually to the rescuervia the display 504, the warnings could also be audible warningsgenerated from, e.g., speakers of the medical device 202.

FIG. 14A is a flow chart illustrating typical steps performed during theplacement of the endotracheal tube during a rapid sequence intubationprocedure, or other intubation procedure, in accordance with embodimentsdescribed herein.

To verify that the intubation tube is properly placed, or remainsproperly placed, the medical device may employ various criteria,examples of which are described in more detail further below. Ingeneral, such criteria may be predetermined, set as default, orotherwise preconfigured in the medical device, or in some cases, a usermay simply provide an input to the medical device as verification thatthe tube has been properly placed or remains in place. Alternatively,the medical device may employ various sensors and appropriatepredetermined criteria to verify proper placement of the ET tube. Suchcriteria may be applicable for when the intubation tube is initiallyplaced and/or when the intubation tube is already placed and the patientis continuously being monitored for any conditions that require an alert(e.g., intubation tube dislodgement). In some cases, the criteria maydiffer depending on whether the tube is initially being placed, orwhether the patient is being monitored for possible tube dislodgement.Described further below, the predetermined criteria may involve variousthresholds, timers, ranges, averages, and/or baselines that are utilizedby the medical device to determine if, or when, physiological parametersare within acceptable operating parameters. Various examples ofcriteria, which are generally described as thresholds, ranges, timers,and baselines, are non-limiting, and other types of predeterminedcriteria may also be implemented.

In step 1402, the medical device 202 may optionally play (audibly) tonesthat convey SpO2 information in accordance with QRS pulses, with thefrequency of the tones varying based on the SpO2 saturation. Forinstance, the medical device may track QRS complexes in the ECG and emita tone corresponding to each QRS peak. The frequency of the tone may behigher or lower depending on the particular level of oxygen saturationdetected, such as SpO2 level. For example, in such a configuration, asthe oxygen saturation level decreases, the associated tone(s) playedwhen the QRS complex is detected goes lower in frequency until the alarmthreshold is reached, which would trigger an alarm. In one embodiment,the threshold level is a user-configurable parameter that is programmedinto the device prior to being deployed for use. Additionally, oralternatively, the medical device is pre-configured with defaultthreshold values (e.g., between 85-88%, between 85-93%, between 85-91%,between 88-91%). As discussed above, the threshold values during thisstep in the overall procedure may be set higher (e.g., 91% duringintubation) than would normally be the case during regular monitoring(e.g., 88% during monitoring post-intubation) because of the elevatedrisk of desaturation at this stage. In yet another embodiment, themedical device 202 includes an option to silence the alarm if, forexample, the threshold is not able to be exceeded even with ventilationand oxygenation.

Or, if the oxygen saturation level maintains a consistent level, theassociated tone(s) played with the pulse/QRS peak with remain about thesame frequency. As a result, the rescuer will be able to obtain anaudible indication of the patient's oxygen saturation at regularintervals, according to the heart beat of the patient.

In the next step 1404, the medical device displays a real-timelaryngoscope video as the rescuer begins placing the endotracheal tube.In the next step 1406, as the ET tube is being placed, the medicaldevice 202 continues to monitor patient vitals, in particular, to trackany potential risk of desaturation, due to depletion of the oxygenreservoir. For instance, during the procedure, the medical device 202determines if the SpO2 is under the threshold (hypoxemia) or if theprocedure timer has expired. If the SpO2 is under the threshold or theprocedure timer has expired, then the medical device 202 activates analarm and displays a warning message to the rescuers in step 1414. Therescuers must then determine whether to continue with the procedure orabort the procedure in step 1416. If the SpO2 is not under the thresholdand the procedure timer is not yet expired, then the medical devicecontinues to determine if the physiological or airway gas measurementsignals are within acceptable limits in step 1408.

If the physiological or airway gas measurement signals are not withinacceptable limits, then the medical device 202 activates an alarm anddisplays the warning message in step 1418. If the physiological orairway gas measurement signals are within acceptable limits, then themedical device 202 determines if the tube placement is stable in step1410. If there is unwanted movement, then the medical device 202activates an alarm and displays the warning message in step 1418. Forexample, as provided above with respect to step 1406, if the SpO2 isoutside of acceptable limits, then an alarm and/or warning notificationmay be provided. As discussed, this alarm may be triggered if oxygensaturation levels fall below a particular threshold. In some case, themedical device may be configured such that the further the oxygensaturation is below the set threshold, the more intense the alarm and/ornotification (e.g., louder audible sound, stronger haptic vibration,flashing visual with optional color change in the visual display,colored highlighting of a box on the display to yellow or red dependingon the severity of the alarm with yellow indicating a warning and redbeing more severe than yellow).

In certain embodiments, this alarm may be triggered if oxygen saturationlevels exhibit a dramatic downward trend. For instance, if the SpO2levels falls from 95% to 90% within a short time period (e.g., within5-10 seconds), then the medical device 202 may make a determination thatthe patient is at risk of desaturation and may then trigger an alarm orwarning notification. Or, if the oxygen saturation levels exhibit asignificant drop (e.g., 5-10%) over the course of the overall procedurefrom a generally constant baseline, then the medical device may alsodetermine that the patient is at risk of desaturation, and so triggerthe alarm/notification. As an example, after preoxygenation, thepatient's oxygen saturation levels may remain relatively high, e.g.,97%, and a baseline may be established. Then after a period of time(relatively long or short), if the oxygen saturation level drops from97% to 91%, then the medical device may trigger an alarm/notification ofa risk of desaturation. In this case, while 91% may be within anacceptable threshold for the general population, such a significant dropin oxygen saturation from a relatively high initial level may be causefor concern that the tissues of the patient are not receiving typicallyaccustomed amounts of oxygen for healthy function.

The alarm thresholds of the medical device may be configurable by auser, for example, prior to use in an emergency. For example, an alarmand/or notification threshold may be 88%, 89%, 90%, 91%, 92%, 93%, oranother appropriate value given the use scenario (e.g., local medicalguidance). In certain embodiments, the alarm/notification thresholds maydiffer depending on whether the medical device is being used in anactive intubation mode (e.g., intubation process is happening), whichmay be distinct from a monitoring mode (e.g., tube has already beenplaced and the patient is being monitored for high risk events such assudden desaturation, swings in blood pressure or heart rate, etc.). Asdiscussed above, the patient may be at higher risk of desaturation whenbeing actively intubated as compared to when the tube has already beenplaced. Accordingly, the trigger(s) for a desaturationalarm/notification may be more sensitive during placement of the tubethan during a post-intubation monitoring state. The medical device mayfurther be able to allow the rescuer to silence thealarm(s)/notification(s) if desired (e.g., oxygen saturation levelsremain relatively low during preoxygenation, yet desaturation has notyet occurred).

In some embodiments, one or more of the airway sensors (e.g., flowsensor) and the ET tube may be outfitted with near-field communication(NFC) transceivers, to detect whether they are in close proximity. Whenthe ET tube is placed, the mask may be removed from the patient, but theairway flow sensor may still remain in the patient airway so as toprovide airway gas measurements. If the tube placement is stable, thenNFC transceivers on the airflow sensor module and the ET tube may beused to provide an indication to the medical device that they have beenassembled and are being used to deliver oxygen to the patient.Accordingly, the indication that the airway flow sensor and the ET tubeare placed in and remain in close proximity for an extended period oftime (e.g., 1 to 5 minutes), e.g., as confirmed by NFC sensor detectionthere between, may be used by the medical device to determine whetherthe ET tube has been placed in an appropriate position relative to thepatient.

In the next step 1420, the medical device 202 determines if the tube isplaced. Typically, this is accomplished by analyzing the data from thesensors such as the flow sensor, and capnography sensor to ensure thatgas is flowing at appropriate rates/volumes in the patient airway, andverify ETCO2 waveforms (e.g., normal waveform returns, indicating thatinspiratory and expiratory flows have returned), which indicate that theintubation procedure was successfully completed. In one embodiment, themedical device 202 identifies proper placement when ETCO2 is below 45mmHg, when the ETCO2 waveform has the correct size, rate, and amplitude,and the oxygen and/or flow sensors are measuring 400 mL in inspiratoryand expiratory flow. In various embodiments, oxygen saturation levels(e.g., from SpO2) are also provided to verify intubation tube placement.While oxygen saturation levels may be relatively delayed due tophysiological processes, such measurements will be provided duringpost-intubation monitoring of the patient. Though, flow sensormeasurements of flow rate and volume in the patient airway may be usedby the medical device (e.g., confirming a minimum level of flow therethrough) for verifying intubation tube placement. Additionally,impedance measurements coupled with auscultation may be another way toverify ET tube placement. In this method, measurements of changes intransthoracic impedance are used to verify that air is entering thelungs via the trachea, as opposed to entering the stomach via theesophagus.

In addition, the medical device 202 could use image processing toanalyze data from the video laryngoscope to determine if, for example,the ETT passed between the vocal cords. If the tube was not placedproperly, then the device returns to the step 1404 and the rescuer needsto begin placing the tube again.

In the next step 1421, the medical device 202 maintains a failed attemptcounter, which keeps tracks of the number of failed attempts. Thiscounter serves multiple purposes. For example, after a first failedattempt the medical device prompts the rescuers re-check previous stepssuch as evaluate bodily fluids in the airway, patient positioning,change of user, laryngoscope blade change, and/or use of a bougie ormucosal airway tool. Prehospital data demonstrates, addressing theseissues before the second intubation attempt significantly increases theprobability of 2nd attempt success. Accordingly, if the first intubationattempt was unsuccessful, a more senior rescuer may then be chosen toperform the second intubation attempt. Then, after a third failedattempt, or a subsequent failed attempt as determined by the deviceconfiguration, the medical device prompts or otherwise suggests that therescuers use an alternative supraglottic airway as an alternative to anETT.

If, the tube was placed correctly, then the medical device moves to thetube placement checklist in step 1422.

FIG. 14B is an exemplary user interface displayed on the medical device202 during the endotracheal tube placement procedure.

In the example embodiment illustrated, key information such as NIBP,SpO2, heart rate, and the procedure timer 531 are displayed. Asdiscussed herein, this procedure timer provides a countdown (e.g., from3 to 8 minutes, depending on how the procedure timer feature isconfigured) indicating how long the rescuers have to preoxygenate beforeperforming intubation. For instance, and as discussed herein, if theprocedure timer expires, then the medical device 202 may generate analarm or warning message to the rescuer that the timer has expired,prompting the rescuer to consider whether to continue forward with theprocedure, go back to the preoxygenation stage, or perform another task.Additionally, if the rescuer uses a laryngoscope, a real-time video feedfrom the laryngoscope is displayed 529. In the illustrated embodiment,the video feed is only displayed on half of the display 504. Inalternative embodiments, the video feed may cover the entirety of thedisplay 504 or an even smaller portion of the display in otherembodiments. In still yet other embodiments, the video feed may betransmitted to another device entirely (not pictured), such as a secondmedical device 202, a tablet, or a remote medical monitoring andguidance location, for example.

FIGS. 15A-15G illustrate several embodiments that may be implemented inverifying tube placement. Specifically, these figures illustrateexamples of tube placement verification using capnography sensors tomeasure ETCO2 or lead/pad to measure transthoracic impedance.

FIG. 15A is an exemplary user interface (dashboard) displayed on themedical device during the tube placement of an intubation procedure. Thedisplay includes specific prompts 706 directly related to specific stepsbeing performed during the intubation using a combination of impedancemeasurements and auscultation by the rescuer to determine whether the ETtube has been correctly placed. Examples of this overall procedure forverifying ET tube placement are described in U.S. Patent Publication2014/0180138, filed on Dec. 17, 2013, entitled “Ventilation Monitoring,”which is hereby incorporated by reference in its entirety. Additionally,the illustrated example displays other relevant information such as ECG512, ETCO2 waveform, 514 heart rate window 510, ETCO2 window 704, whichshows the ETCO2 value (e.g., 32 mmHg). In general, auscultation mayinclude manual listening of sounds from the heart, lungs, or otherorgans, typically with a stethoscope, or may involve other methods suchas acoustic cardiography performed by a device such as an Audicor® RT4.0 AM sensor manufactured by Inovise Medical, Inc. of Portland, Oreg.to determine breath sounds or in some cases, a lack thereof. Theacoustic sensors can include an accelerometer, microphone, or otheradditional sensors. The acoustic sensors are configured to detect andconvey acoustic signals, such as those created by activity (e.g.,movement) of the lungs or stomach of the patient. In someimplementations, the acoustic sensor can comprise a three axismultiple-channel MEMS accelerometer. The acoustic sensor may comprise athree-channel accelerometer. In some implementations, a first channel ofthe three-channel accelerometer is configured to monitor sounds producedby a heart of the patient, a second channel of the three-channelaccelerometer is configured to monitor a respiration of the patient, anda third channel of the three-channel accelerometer is configured tomonitor movement of the patient. The acoustic three-channelaccelerometer can be configured to sense movement in each of threeorthogonal axes. An example of an accelerometer which may be utilized insome implementations is a LIS344ALH accelerometer, available fromSTMicroelectronics.

In some implementations the acoustic sensor comprises a microphone. Theacoustic sensor and associated electronics may be configured to monitorany one or more of a patient's respiration, a patient's heart sounds, apatient's position, and an activity level of a patient. The acousticsensor and associated electronics may additionally or alternatively beconfigured to monitor other sounds which may be indicative of a state ofhealth of a patient, for example, gastrointestinal sounds or the soundsof snoring or the absence of such sounds, for example, to provide anindication of the patient experiencing sleep apnea. The acoustic sensormay provide signals indicative of the patient's respiration on a firstchannel, signals indicative of the patient's heart sounds on a secondchannel, and signals indicative of the patient's position on a thirdchannel. In other implementations, the different channels may beutilized to provide signals indicative of more than one physiologicalparameter or other parameter associated with the state of the patient.For example, in one implementation, the acoustic sensor may providesignals indicative of the patient's heart sounds on a first channel,signals indicative of the patient's respiration (lung sounds) on asecond channel, and signals indicative of the patient's body position onany or all of the first, second, and third channel. It should beappreciated that dependent on the underlying parameter that is beingmonitored, multiple signals related to the parameter being monitored maybe received over a single channel or a number of different channels.

Spectral components of lung and stomach sounds can vary vastly in regardto placement of the intubation tube. A signal processing unit maycompare spectral components of acoustic signals measured by the acousticsensor(s) with spectral components of lung and esophageal sounds havinga particular spectral pattern. For example, the sound of aspiratinglungs can be of a higher frequency than spectral components of stomachnoises. Accordingly, the signal processing unit may compare spectralcomponents of the acoustic signal(s) with a predetermined threshold todetermine placement of the intubation tube in the trachea. Thepredetermined threshold can be indicative of the discrepancy in lung andesophageal spectral components. In some implementations, if the spectralpattern involves spectral components exhibiting a frequency componentabove the predetermined threshold, the signal processing unit canindicate to an operator of the system (e.g., a clinician) that theintubation tube has been properly placed in the trachea. In someimplementations, if the spectral pattern exhibits spectral componentsfrequency characteristics falling below the predetermined threshold, thesignal processing unit indicates or conveys an alert that the intubationtube has been improperly placed in the esophagus. Proper placement ofthe intubation tube can occur if the intubation tube is placed in aposition such that the intubation tube is effective (e.g., positionedaccording to design specifications). In some implementations, thepredetermined threshold can be determined based on patient age, gender,height, weight, and/or physical condition. In some implementations, thethreshold value can be a discrete value. In some implementations, thethreshold value can include a range of frequencies. In some embodiments,an acoustic sensor may be used in combination with an airflow sensor, toverify that a positive pressure ventilation breath has reached thelungs. For example, the medical device may receive data indicative ofthe airflow in the patient's airway from the airflow sensor to determinethat a positive pressure breath has been given. And then the medicaldevice may receive and process the acoustic information regarding theairflow in the patient's lungs via the acoustic sensor(s) placed on thepatient. In some embodiments, a physiological baseline regarding airflowin the patient's lungs after initial placement of the ET tube may bedetermined according to the received acoustic information, having adistinguishable spectral pattern with spectral components. The medicalmay then determine whether the ET tube is or remains properly placedbased on a deviation from the determined physiological baseline, andpresent on a user interface an output of that determination of whetherthe ET tube is or remains properly placed. The determined baseline maybe an initial baseline that is determined when the ET tube is initiallyplaced, or the baseline may be a dynamic baseline that is continuallyupdated (e.g., moving average of spectral components that arecontinuously being monitored) as the tube remains in position and moreventilation readings are taken. The initial baseline may include anaverage of initial spectral components received upon initial placementof the tube. When the medical device detects a substantial deviationfrom the physiological baseline (initial and/or dynamic), such as apercentage difference between a current spectral pattern and the initialand/or dynamic baseline, then an alert may be given that the tube may bedislodged.

Examples of systems and methods that may be used to assist caregivers inverifying that an intubation tube has been and/or remains properlyplaced using an acoustic sensor are described in U.S. Pat. No.9,826,956, entitled “System and methods for positioning an intubationtube,” which is hereby incorporated by reference in its entirety.Various examples of interfaces for providing assistance to a user inplacing the intubation tube including necessary auscultation steps areprovided below.

FIG. 15B is a diagram of a testing screen 1502 of the medical device 202showing testing in progress, the medical device 202 configured in amanual mode for use with capnography sensor 218 and a protocolcomprising three auscultations according to an example embodiment. Inthe embodiment, the source is configured to “CO2” using soft key 1508,which means that only the capnography sensor 218 of FIG. 2 will be usedas an automated means to detect the subject's breath. Manual mode, whichrequires the user to confirm a positive result of each auscultationperformed using soft key 1516, is configured by the user using soft key1510. The 3-auscultation protocol, which includes user auscultations ofthe left lung, right lung and abdomen, is configured by the user usingsoft key 1512. At any point, the testing may be canceled by using softkey 1518.

In the embodiment, since the capnography sensor 218 is being used withmedical device 202, capnograph 1504 is displayed on testing screen 1502.If a capnography sensor was not being used, i.e., “Source” correspondingto soft key 1508 was configured to “Electrodes”, then a capnograph wouldnot be displayed and a transthoracic impedance graph would be displayedinstead. If both the capnography sensor 218 and electrodes 125 a and 125b were being used i.e. “Source:” was configured to “both”, then both thecapnograph and transthoracic impedance graph may be displayed on screen1502.

According to testing screen 1502, the present status 1520 of the testingindicates “Waiting for ventilation”, which means that the medical device202 is waiting for capnography sensor 218 to detect a positive air flowfrom ventilation bag 112 of FIGS. 1A and 1B. The results of Test 1 1522indicate that the test passed. The results of Test 1 1522 further showthat a confirmation was provided by the user that subject's left lungwas auscultated and 4 breaths were detected by capnography sensor 218.

Further, according to testing screen 1502, the result of Test 2 1524indicates that capnography sensor 218 detected 1 breath, however, sincethe user has not confirmed a breath from auscultation of the right lung,test 2 has not completed. Test timer 1506, which was originally set to60 seconds using soft key 1514, indicates that there are 35 seconds leftin the overall testing period including the time to complete Test 2 andTest 3. If Test 2 and Test 3 are not completed within the time periodleft, which is 35 seconds, then the overall testing will fail and Status1502 will report “Failed” and the reasons for the failure.

FIG. 15C is a diagram of a testing screen 1502 on the medical device 202showing the testing has passed, the medical device 202 configured in amanual mode for use with capnography sensor 218 and a protocolcomprising three auscultations according to an example embodiment. Inthe embodiment, screen 1502 shows a continuation of the testing as shownin the screen of FIG. 15C. According to screen 1502, the results of Test2 1524 indicate that the user has confirmed with soft key 1516 that thesubject's right lung has been auscultated and at least one breath wasdetected. Further, since capnography sensor 218 has detected at leastone breath, 3 breaths in this case, Test 2 has passed.

In the embodiment, the results of Test 3 1526 indicate that the user hasconfirmed with soft key 1516 that the subject's abdomen has beenauscultated and no breathing was detected. Further, since capnographysensor 218 has detected at least one breath, 2 breaths in this case,Test 3 has passed. Since each of Test 1, Test 2 and Test 3 have passed;overall status 1520 indicates that the testing has passed. In anembodiment, the results of the overall testing including the results ofeach of the Tests, e.g. Test 1, Test 2 and Test 3, are saved in memory,for example, in a FLASH memory such as non-volatile memory 209 of FIG.2. At this point, the user may exit the Ventilation Monitor Testing bypressing soft key 1518.

FIG. 15D is a diagram of a testing screen 1502 on the medical device 202showing that the testing has failed, the medical device 202 configuredin a manual mode for use with capnography sensor 218 and a protocolcomprising three auscultations according to an example embodiment. Inthe embodiment, screen 1502 shows a continuation of the testing as shownin screen 1502 of FIG.

In the embodiment, the results of Test 3 1524 indicate that the test hasfailed, which has caused the overall testing Status 1520 to indicatefailure. Although the capnography sensor 218 detected 12 breaths of thesubject, the user did not confirm a positive result of the subject'sabdominal auscultation in Test 3 using soft key 1516 within the timerperiod. As a result, test timer 255 counted down to 0 as indicated at1520 and the overall testing failed. Reasons for the failure of theoverall testing 1521 indicate that the timer expired and that aconfirmation in Test 3 was not received.

FIG. 15E is a diagram of a testing screen 1502 on the medical device 202showing that the testing has failed, the medical device 202 configuredin a manual mode for use with capnography sensor 218 and a protocolcomprising five auscultations according to an example embodiment. In theembodiment, screen 1502 shows that a user configured the ventilationmonitor testing using soft key 1512 to require 5 auscultations to beperformed on the subject including auscultations of the subject's leftlung, right lung, abdomen, left axillary and right axillary.

Testing screen 1502 shows that Tests 1 through 4 have passed, however,Test 5 has failed. In Test 5 1528, although the user confirmed that atleast one breath was detected during auscultation of the subject's rightaxillary, capnography sensor 218 did not detect at least one breath.Screen 1502 shows the results of Test 5 1528, which indicate that thesubject's breath count did not increment (remained at 0) and Test 5failed as a result. The failure of a capnography sensor 218 to detect abreath may be due to a number of reasons such as endotracheal tube 129of FIG. 1B becoming dislodged from the subject's trachea or the subjectmay have stopped breathing. As the medical device 202 was waiting forcapnography sensor 218 to detect a breath from subject 102, test timercounted down to 0 as indicated at 1506 and triggered a failure of theoverall testing 1520. Screen 1502 further indicates that reasons 1521for the failure of the overall testing was that the timer expired and nobreath was detected in Test 5.

FIG. 15F is a diagram of a testing screen 1502 on the medical device 202showing that the testing has failed, the medical device 202 configuredin a manual mode for use with capnography sensor 218, electrodes 125 aand 125 b, and a protocol comprising five auscultations according to anexample embodiment. In the embodiment, screen 1520 shows that a userconfigured the ventilation monitor testing using soft key 1512 torequire 5 auscultations to be performed on the subject includingauscultations of the subject's left lung, right lung, abdomen, leftaxillary and right axillary. Further, screen 1502 shows that the userconfigured the source 1508 to be both the capnography sensor 218 andelectrodes 125 a and 125 b of FIG. 1B. As a result, both a capnograph1332 and transthoracic impedance waveform 1534 are shown in screen 1000.

Testing screen 1502 shows that Tests 1 through 3 have passed, however,Test 4 1530 has failed. In Test 4, although the user confirmed that atleast one breath was detected during auscultation of the subject's leftaxillary, system 200 configured with capnography sensor 218 andelectrodes 125 a and 125 b indicted a failure to detect a breath fromsubject 102. Since source 1508 is set to “both”, the system 200 mustdetect a breath from both capnography sensor 218 and electrodes 125 aand 125 b. Screen 1502 shows the results of Test 4 1530, which indicatethat the subject's breath count did not increment (remained at 0) andTest 4 failed as a result. Screen 1502 further indicates that reasons1521 for the failure of the overall testing was that the timer expiredand no breath was detected in Test 4 with respect to the transthoracicimpedance testing using electrode 125 a and 125 b. Since source 1508 wasset to “both”, even though system 200 may have detected a breath usingcapnography sensor 218, the overall testing failed since no breath wasdetected with respect to the transthoracic impedance testing.

The failure of the transthoracic impedance to detect a breath may be dueto a number of reasons such as electrode 125 a or electrode 125 bbecoming disconnected from the subject's chest or back or the subjectmay be in repertory distress. As medical device 202 was waiting for thetransthoracic impedance testing using electrodes 125 a and 125 b todetect a breath from subject 102, test timer 1506 counted down to 0 andtriggered a failure of the overall testing indicated at 1010.

In another embodiment, if source 1508 was set to “either” for example, atest such as Test 4 could pass providing that system 200 detected abreath using either capnography sensor 218 or transthoracic impedancetesting and the user confirmed the presence of a breath by auscultation.

FIG. 15G is a diagram of a testing screen 1502 on the medical device 202showing that the testing has passed, the medical device 202 configuredin an automatic mode for use with capnography sensor 2180, electrodes125 a and 125 b, and a protocol comprising five auscultations accordingto an example embodiment.

Screen 1502 shows that the user configured the mode to be automaticusing soft key 1510. As a result, the user may confirm a positive resultfor each of the auscultations performed by pressing confirm soft key1516 once when the auscultations are completed but before the expirationof test timer at indicated at 1516. For example, according to screen1502 the user confirmed a positive result for each of the auscultationsas indicated in result of Test 5 1528. Testing screen 1502 shows thateach of Tests 1 through 5 has passed and the status 1520 for the testingindicates “Passed.”

In some embodiments, an airflow sensor may be used in theimplementations described above with respect to intubation assist. Thatis, the airflow sensor placed in the patient airway may provide aninitial input to the medical device and/or portable computing devicethat a positive pressure breath has been given and that confirmationwith one or more physiological sensors (e.g., capnography, transthoracicimpedance, acoustic sensor(s)) may subsequently be required, asdiscussed above, followed by auscultation at various sites (e.g., leftlung, right lung, abdomen, left axillary, right axillary). That is, thephysiological measurement may be correlated with the detected airflow inthe patient's airway to confirm that the ventilation breath initiateddetected by the airflow sensor has reached the patient's lungs. Forexample, when the airflow sensor detects air flow in the patient airwaydue to a positive pressure breath, a timer may be initiated that sets aninterval for confirmation with one or more physiological parameters,such as those described above, to occur. If the set interval expiresbefore such confirmation is received, then an alert may be providedindicating that the air flow provided from the positive pressure breathhas not reached the lungs. However, if physiological confirmation isreceived before the set interval expires, then the medical device maymove on to the next step where a positive result of auscultation is tobe confirmed. It should be appreciated that embodiments discussed belowwith respect to FIGS. 16A-16I, while described in the context ofpost-intubation monitoring, may be used in conjunction with assistingcaregivers in the initial intubation tube placement.

FIG. 16A is a flow chart illustrating typical steps performed during theverification of the endotracheal tube placement. Verification of tubeplacement is an important step to ensure that the endotracheal tube wascorrectly placed within the patient's lungs. A common mistake madeduring intubation is for the rescuer (or caregiver) to accidentallyplace the endotracheal tube into the esophagus of the patient. When thisoccurs, the patient 102 is deprived of ventilation and oxygenation, andis at a significantly greater risk for aspiration as a result of gastricinsufflation. Failure to detect and address esophageal intubation canlead to serious injury or death.

In the first step 1600, the medical device 202 displays the relevantdata e.g., flow rate in the patient's airway, oxygen in the airway,NIBP, SpO2, heart rate, ECG waveform, and ETCO2. In step 1604, themedical device 202 may prompt the rescuers 104, 106 to check for chestmovements and misting of tube upon ventilation. In the next step themedical device 202 verifies that the physiological or airway gasmeasurement signals (e.g., ETCO2, O2, flow rate and volume) are withinlimits. Next, in step 1606, the medical device 202 verifies ETCO2waveform, e.g., to differentiate between esophageal and trachealplacement. In step 1608, the medical device 202 verifies the oxygendelivery in the airway via the respective oxygen sensor as well as therate and volume of the flow using the respective flow sensor. Next, themedical device determines if any of these verifications failed. If anyverifications failed, then the medical device activates an alarm in step1612. If no verifications failed, then the medical device verifies NFCtransceivers on airflow sensor module and ET tube to confirm proximitythere between, that the BVM is on the patient in step 1614.

Lastly, the medical device may use information from the sensors 210-221to detect patient data from sensors (e.g., sensors for detecting motion,displacement, velocity, acceleration) on patient chest, forehead, ETtube and mask to track relative location and orientation, changes inlocation and orientation in step 1616.

FIG. 16B is a flow chart illustrating steps performed during the postintubation verification (e.g., step 326) in accordance with anembodiment. Once intubation has been completed FIGS. 16E-16I illustrateexamples of continuous tube placement verification using capnographysensors, leads/pads to measure transthoracic impedance, additionallyusing a flow sensor to monitor air flow in the airway being provided tothe patient. While the user interface display provides a dashboardconfiguration that shows the results of ET tube verification in thecontext of post-intubation monitoring, it can be appreciated that otherconfigurations and interfaces may be possible. It should also beunderstood that embodiments discussed with respect to continuousmonitoring of the patient post-intubation to verify that the intubationtube is properly placed may be applicable for assisting a caregiver ininitially placing the intubation tube.

While FIG. 16B is directed to an implementation for post intubationmonitoring, as noted above, these steps could also be implemented duringthe initial intubation procedure (e.g., step 328). For example, when aventilation breath is detected via the airflow sensor, in order toconfirm that the ventilation breath has reached the lungs, the medicaldevice 202 may then utilize sensors (e.g., capnography, impedance,acoustic) and different thresholds to determine whether the breath hasappropriately reached the lungs, leaking, and/or tube dislodgement. Thisis accomplished by a comparison of measured physiological information(e.g., CO2 information, transthoracic impedance, acoustic information)to a predetermined criterion that should be satisfied for the medicaldevice to determine that the ventilation breath has entered the lungsand, hence, the intubation tube has been properly placed. For example,during the initial intubation procedure, after the airflow sensordetects the presence of air in the patient's airway, the predeterminedcriterion for verifying that the air has reached the lungs may includeappropriate thresholds (or ranges) for breath detection, e.g., valuesover 5 mm Hg for ETCO2 may indicate that the intubation tube isinitially properly placed, for example that it is properly placed in thetrachea such that airflow in and out of the lungs can occur. Duringinitial tube placement, in some cases, the acceptable threshold in thecase of ETCO2 could be lower in comparison to that when used forpost-intubation monitoring, or in some cases, the acceptable thresholdin the case of ETCO2 could be similar to that when used forpost-intubation monitoring. Some examples of thresholds to indicate thatthe tube has been placed and that a ventilation breath has entered thelungs may be, for example, 2-10 mm Hg, 5-10 mm Hg, 5-7 mm Hg, 2-5 mm Hg,2 mm Hg, 5 mm Hg, 7 mm Hg, 10 mm Hg, amongst others. In some cases,during the initial tube placement procedure, the acceptable range may bewider (broader) with the lower end of the range including a value lowerthan what may be used for post-intubation monitoring (e.g. 0 to 50 mm Hgfor ETCO2, 2 to 40 mm Hg, 5 to 35 mmHg, etc.) in comparison to when thealready intubated patient is being monitored for possible tubedislodgement, leakage, etc. The benefit of this comparatively widerinitial range is that the medical device 202 may be able to detect andconfirm a number of different types of breaths, which may be helpfulduring an intubation procedure where no initial baseline may have beenestablished, so as to verify that the tube has been placed in the airway(e.g., and not in the patient's esophagus).

Alternatively, or in addition, a prior baseline (e.g., TTI) may be takenand a comparison upon initial tube placement may be made to the priorbaseline to determine if the tube has been properly placed. TTI may be apreferable physiological measurement when taking a prior baselinebecause the patient will exhibit a TTI value even if a tube is not inplace.

Upon verification of tube placement, the medical device 202 couldautomatically (or upon manual activation by a user) switch to analternative threshold and/or range, or may maintain similar criteria forverifying that a breath has entered the lungs. In some cases, thealternative threshold and/or range may be narrower than that used forthe initial intubation placement procedure, with the lower end of therange higher than the previous threshold or range (e.g. 5-10 mm Hg, 5-12mm Hg, 7-12 mm Hg, 7 mm Hg, 10 mm Hg, 12, mm Hg, etc.). This narrowerrange is another example of predetermined criterion that may be used todetermine whether the ET tube is and/or remains placed in a desirableposition for the patient to be appropriately receiving positive pressureventilation breaths (from bag or from ventilator device). The advantageof utilizing this narrowing range would be the ability to detect (andgenerate alerts) upon smaller deviations that are the result of, e.g.,tube leakage or tube dislodgement. In various embodiments according tothe present disclosure, the medical system may obtain one or morebaseline values for breaths pre and post intubation and thus anydeviation from the baseline could indicate that a problem (e.g., tubedislodgement, leakage, poor seal, etc.) may have arisen. Duringpost-intubation monitoring, there may also be an appropriate acceptableupper threshold or end of the range for ETCO2 which, when exceeded, maytrigger a different type of alert. For example, if the ETCO2 hasincreased for example, past 30 mm Hg, 35 mm Hg, 40 mm Hg, 45 mm Hg, oranother value, then the medical device may generate an alert informing acaregiver to check the patient, for example, in the even thatspontaneously respiration or return of spontaneous circulation (ROSC,e.g., in the case of cardiac arrest) has occurred.

Various types of baselines may (e.g., via capnography, transthoracicimpedance, acoustic sensing, amongst others) be taken at differentpoints in the intubation process. Such baselines may serve as aphysiological measurement of whether ventilation air provided via theintubation tube has reached the patient's lungs in a desirable manner.For example, when a positive pressure breath is detected by the airflowsensor, one or more physiological measurements that appreciably deviate(e.g., greater than 10%, 20%, 30%, 40%, 50%, etc.) from a baselineobtained previously, pre-intubation, may provide an indication that theintubation tube has been misplaced, dislodged, started to leak, etc.Though, if the physiological measurement(s) do not significantly deviate(e.g., remains within 10%, 20%, 30%, 40%, 50%, etc.) from the previouslytaken baseline, then it may be determined that the intubation tube isproperly placed or remains in proper place.

A baseline may be taken prior to the intubation procedure, to assist inthe ET tube placement procedure. In such a case, the physiologicalmeasurement(s) are taken to obtain a prior baseline before an attempt ismade to insert the ET tube. When the ET tube is inserted into thepatient's trachea and a positive pressure ventilation breath has beengiven, an appropriate change in the physiological measurement(s) ascompared to the prior baseline may indicate that ET tube serves as asuitable conduit through which the ventilation breath is able to reachthe lungs. Such changes in the physiological measurement(s) to detectwhether the ET tube is properly placed may be akin to the predeterminedcriteria discussed herein, for example, deviations from the priorbaseline, exceeding or remaining below a threshold, falling within oroutside a range, for example. For instance, the prior baseline beforeintubation is attempted may record an ETCO2 value of 0 mm Hg. Uponsuccessful ET tube placement, the ETCO2 value may increase, for example,to 20 mm Hg, which is a significant enough deviation from the priorbaseline to confirm that the ET tube has been properly placed. Or, theprior baseline before intubation is attempted may record a first TTIvalue. When the ET tube has been successfully placed, a second TTI valuemeasured upon the patient receiving a ventilation breath may be greaterthan the prior baseline (first TTI value) such that the medical devicemay confirm that the ET tube is properly placed. As discussed above, itmay be preferable to use TTI to obtain a prior baseline when firstinitiating placement of the ET tube because TTI provides a mechanicalmeasurement of the patient, regardless of the physiological condition.This way, a comparison may be made between a first TTI value obtainedbefore the ET tube is placed to a second TTI value obtained after the ETtube is placed.

Or, a baseline may be taken immediately upon initial completion of thetube placement procedure, to monitor whether the ET tube remains inproper position, or if a problem has arisen with the ET tube placement.In this case, the physiological measurement(s) are taken right after thetube has been inserted into the patient's airway to obtain an initialbaseline of positive pressure ventilation breaths. After the initialbaseline is taken, the patient is continuously monitored, bothphysiologically and mechanically (e.g., detecting patient movement aswell as whether the tube remains in place). During this post-intubationmonitoring phase, the airflow sensor may detect the presence of aventilation breath in the patient's airway, and the subsequentphysiological measurement(s) recorded may be compared to the initialbaseline to indicate whether ET tube remains as a suitable conduitthrough which the ventilation breath(s) are able to reach the lungs.Changes in the physiological measurement(s) to detect whether the ETtube remains properly placed may be similar to the predeterminedcriteria discussed herein, for example, deviations from the priorbaseline, exceeding or remaining below a threshold, falling within oroutside a range, for example. For instance, the initial baseline afterintubation is completed may record an ETCO2 value (e.g., average ETCO2value over several breaths) of 20 mm Hg. If the ET tube remains properlyplaced, then subsequently recorded ETCO2 values may be within anacceptable range around the initial baseline. However, if the ET tubebecomes dislodged or if a leak occurs, then the subsequently recordedETCO2 values may drop, for example, to 5 mm Hg or lower, which may be asignificant enough deviation from the initial baseline to result in analert (e.g., on the display of the medical device, or to a remotestation or mobile device) that the ET tube placement should be checked.Or, if subsequently recorded ETCO2 values are substantially above theinitial baseline, then it may be possible that the patient condition haschanged, for example, improved such that spontaneous respiration or ROSC(e.g., in the case of cardiac arrest) has occurred. Accordingly, theremay an alert that the patient should be checked, as discussed furtherbelow. Similarly, the initial baseline after intubation may include afirst TTI value (e.g., average TTI value over several breaths). If theET tube remains properly placed, then subsequently recorded TTI valuesmay be within an acceptable range around the initial baseline. However,if the ET tube becomes dislodged or if a leak occurs, then thesubsequently recorded TTI values may drop enough such that a substantialdeviation from the initial baseline may result in an alert (e.g., on thedisplay of the medical device, or to a remote station or mobile device)that the ET tube placement should be checked.

Furthermore, a dynamic baseline may be taken after completion of thetube placement procedure when the patient is being continuouslymonitored for any physiological (e.g., oxygen saturation, bloodpressure, CO2 production, metabolic parameters, etc.) or mechanical(e.g., patient movement, tube placement) changes. The dynamic baselineis similar in concept to the initial baseline, except the dynamicbaseline may be continually updated, as discussed further below invarious embodiments. In fact, when the ET tube is initially placed, thedynamic baseline and the initial baseline may be the same. Hence, thephysiological measurement(s) from positive pressure ventilation breathsare continually taken as the patient is being monitored to update thedynamic baseline. In this post-intubation monitoring phase, the airflowsensor may detect the presence of a ventilation breath in the patient'sairway, and the subsequent physiological measurement(s) recorded may becompared to the dynamic baseline to indicate whether ET tube remains asa suitable conduit through which the ventilation breath(s) are able toreach the lungs. Changes in the physiological measurement(s) to detectwhether the ET tube remains properly placed may be similar to thepredetermined criteria discussed herein, for example, deviations fromthe prior baseline, exceeding or remaining below a threshold, fallingwithin or outside a range, for example.

Taking a baseline may be preferable when measuring TTI values becausethe TTI may vary significantly from patient to patient. Accordingly,when making a determination that the ET tube remains properly placed oris no longer properly placed, subsequently recorded TTI values may becompared to the baseline, rather than a particular number or range.

It should be appreciated that multiple different types of physiologicalmeasurements (e.g., CO2, TTI, acoustic) may be used to confirm that aventilation breath has reached the lungs, individually or in combinationwith one another. Such a combination of sensors may provide forredundancy in the system. For example, if one of the physiologicalsensors is unavailable (e.g., failed, unplugged, provides a parameterthat is not relevant), then other sensors may be able to provide theappropriate confirmation. For instance, if both capnography and TTIsensors are employed, yet capnography is not yet plugged in andimpedance sensors are placed on the patient, then TTI may be usedinitially. Conversely, if impedance sensors are not yet placed on thepatient and the capnograph is available, then CO2 information may beused initially. Or, if all types of sensors are available, then themedical device may implement accordingly.

Returning to FIG. 16B, in the first step 1450, after it has beenconfirmed that the ET tube has been placed via the intubation assistfeature, the medical device 202 may automatically enter a monitoringmode (e.g., testing and verification mode). Alternatively, the rescuers104, 106 may manually enter the monitoring mode via a button, softkey,knob, or touchscreen interface, for example. This monitor mode causes amonitoring dashboard 1545 to be displayed on the display 1502 of themedical device 202.

In the next step 1452, the rescuers 104, 106 provide oxygen to thepatient 102 (e.g., via BVM or portable ventilator). Data from the flowsensor 127 determines/confirms whether a positive pressure breath hasbeen given by detecting air flow in the patient's airway in step 1453.In one embodiment, a timer may be initialized upon entering intomonitoring mode. Upon expiration of the timer an alert would bedisplayed indicating that no airflow is detected and the rescuers shouldcheck for clogged airways, whether there is a leak in the airway, thecuff of the airway, or if some component of the BVM or endotracheal tubehas become disconnected, to list a few examples. Determination ofwhether a ventilation breath has entered the lungs before expiration ofa timer is yet another example of a predetermined criterion that can beimplemented to determine of the ET tube is properly placed. In thisexample, the expiration of the timer is indicative that the tube is notdesirably placed because while the presence of airflow indicative of agiven breath was detected, there was no confirmation that the givenbreath has reached the lungs in the allotted time.

If the flow sensor 127 detects air flow in the airway (e.g., from oxygendelivered to the patient 102), then an indication is displayed in step1454 that a positive pressure breath has been detected. In the next step1456, a timer is initialized that sets an interval for confirmation thatthe positive pressure breath has reached the lungs. A physiologicalmeasurement may be used as correlation with the detected airflow in thepatient's airway to confirm that the ventilation breath initiateddetected by the airflow sensor has reached the patient's lungs. Thistimer may have a default value such as 10 seconds or a default rangesuch as between 5-10, 10-15, 15-20, 5-15, of 10-20 seconds, to list afew examples. Additionally, the medical device may further include aseries of user-selectable preset times (e.g., 5, 10, 15, 20, 25, 30seconds, to list a few examples) for the timer. In still anotherembodiment, the timer may be a user programmed time value based on aphysician/administrator decision. While the time is counting down tozero, in step 1458, the one or more physiological sensors measurephysiological information of the patient (e.g., pads/lead 125 a, 125 bmeasuring transthoracic impedance, a capnography sensor 218, acousticsensor, or other sensor for confirming that the breath has entered intothe lungs). This information may then be used to determine whether airfrom the delivered breath detected in step 1453 has entered (and/orexited) the lungs. In general, the medical device 202 performs thisdetermination by comparing the measured physiological information (e.g.,ETCO2 or transthoracic impedance) against one or more predeterminedcriteria. For example, the predetermined criterion could include anETCO2 value exceeding a predetermined threshold (e.g., greater or lessthan 50% of an original baseline, such as an initial or dynamicbaseline), an ETCO2 value falling within a desired range, an average ofmultiple ETCO2 values exceeding a threshold, the average of multipleETCO2 values exceeding a threshold, a trend in the ETCO2 values, anaveraged ETCO2 value being greater or less than a percentage of a movingaverage of a plurality of previously measured ETCO2 values, an averagedETCO2 value being greater or less than a percentage of a moving averageof a plurality of previously measured ETCO2 values, or another suitablemethod of confirming whether the ventilation breath has properly enteredinto the lungs.

Additionally, the predetermined criteria may utilize alternatively, orin addition, a measure of transthoracic impedance. For example, thepredetermined criterion may include transthoracic impedance valueexceeding a predetermined threshold (e.g., greater or less than 50% ofan original baseline, such as an initial or dynamic baseline), atransthoracic impedance value falling within a desired range, an averageof multiple transthoracic impedance values exceeding a threshold, theaverage of multiple transthoracic impedance values exceeding athreshold, a trend in the transthoracic impedance values, an averagedtransthoracic impedance value being greater or less than a percentage ofa moving average of a plurality of previously measured transthoracicimpedance values, an averaged transthoracic impedance value beinggreater or less than a percentage of a moving average of a plurality ofpreviously measured transthoracic impedance values. Specific,non-limiting examples, of predetermined threshold and predeterminedcriterion are described in detail below.

In another specific example of predetermined criteria, if sufficientexpiratory CO2 of approximately at least 5 mm Hg, is detected and/or atransthoracic impedance (TTI) waveform or amplitude is indicative of alung volume change of at least 150 mL have been detected, within theallotted time interval set by the timer, then it may be confirmed thatthe positive pressure ventilation breath has entered into the lungs and,hence, that the ET tube remains properly placed.

In another example, impedance may be measured to be from approximately1.5 ohms to 2.5 ohms. However, in yet another example, a range from 0.5and 1.0 ohms may also be measured. These values may be measured by theimpedance sensor and then processed and amplified by the processor ofthe medical device. In one example, the signal is sent through one ormore high, low, and/or bandpass filters in order to remove unwantedvalues below a desired level. Peaks may then be identified and thoseremaining peaks are amplified (e.g., by squaring the peak values). Thissquaring causes the values of the peaks to increase, where the largestpeaks increase disproportionally more in comparison to other peaks. Thusmaking distinction of peaks easier.

While the range may vary from person to person, the change in impedanceis identifiable and detectable by the medical device 202. Still anotherexamples of a predetermined criterion includes an ETCO2 value in therange between approximately 35-45 mm Hg, which may be considered typicalfor a healthy patient. Thus, if the measured ETCO2 value is within thisrange, the medical device is able to determine that measured ETCO2 valuesatisfies the predetermined criterion. The thresholds for intubation andpost intubation could be based around these values. For example, instill another non-limiting example, the predetermined criterion could bebased on the lower thresholds for breath detection via ETCO2, whichinclude values such as be 5 mm Hg, 10 mm Hg, 15 mm Hg, or 20 mm Hg, tolist a few examples. That is, the medical device would indicate a breathupon at least a measurement of, e.g., 5 mm Hg and anything lower wouldbe filtered out as “noise.”

Similarly, in another non-limiting example, the predetermined criterionfor determining that the intubation tube remains properly placed couldbe adjusted to somewhere between 25-30 mm Hg after intubation. Asbefore, of any ETCO2 values falls below that threshold, an alert may betriggered to indicate that there is a possible tube leak or the tube hasbecome dislodged.

In some embodiments, the predetermined criterion may involve a series ofinitial and/or dynamic baseline measurements obtained from capnographyand/or TTI immediately following a successful intubation, and for thedynamic baseline case, continuously updated baseline while the intubatedpatient is being monitored. For example, substantial changes in ETCO2may provide an indication that positioning of the ET tube has affectedthe patient, for example, become dislodged, started to leak, or has beenmisplaced. Subsequent measurements of ETCO2 and TTI for subsequentbreaths may be compared to the baseline. If ETCO2 or TTI waveformamplitude decreases by no more than, for example, approximately 20%, ascompared to baseline, then it may be confirmed that the positivepressure ventilation breath has entered into the lungs and, hence, thatthe ET tube remains properly placed. Alternatively, the conversioncoefficient for converting TTI waveform amplitude to lung volume changemay be estimated based on measured tidal volume from the flow sensor andthe TTI waveform amplitude immediately following successful intubation.If the conversion coefficient increases by no more than, for example,approximately 20%, or other predetermined threshold, then it may also beconfirmed that the positive pressure ventilation breath has entered intothe lungs and, hence, that the ET tube remains properly placed. Usingthe ETCO2 signal the medical device 202 is able to identify patternsthat could indicate displacement of the ETT or a significant failure toventilate. In one embodiment, described in further detail below, a ±50%change in the ETCO2 may trigger an alarm based on a number of breaths(e.g., 2-10 breaths) should, for example, 2 or more consecutive ornon-consecutive breaths (e.g., 2-5 breaths in consecutive succession orinterposed by one or more breaths, etc.) be >±50% of a moving average ofthe ETCO2 of the number of breaths. For instance, for 2 or moreconsecutive or non-consecutive breaths (e.g., 2-5 breaths in consecutivesuccession or interposed by one or more breaths, etc.) where ETCO2 <50%of the moving average, the visual alarm may indicate that the ETCO2 islow and that the airway should be checked, for example, “Low ETCO2,Check Airway.” Conversely, for 2 or more consecutive or non-consecutivebreaths (e.g., 2-5 breaths in consecutive succession or interposed byone or more breaths, etc.) where ETCO2 >50% of the moving average, thevisual alarm may indicate that ETCO2 levels have changed and that thepatient should be checked, for example, “ETCO2 Change, Check Patient.”In general, the benefit of using the average of consecutive breaths isto reduce and/or eliminate “noise” from outliers that can occur. Thisalgorithm is described in further detail in FIGS. 16C and 16D.

Alternatively, rather than use of a timer, one or more physiologicalparameters may be used for confirmation (e.g., without a timer). Forexample, rather than using a countdown timer for expiration, the medicaldevice 202 may simply wait until the next “cycle.” For example, afterthe BVM is used to provide air into the airway, the medical device couldthen wait until either the breath is detected via one of parameters(e.g., ETCO2 or TTI) or wait until the BVM is used again. Upon detectionof air in the airway from the BVM, without a corresponding confirmation,a lack of exhalation (and a failed test) may be indicated.

If information from one or more of the physiological sensors hasconfirmed that the positive pressure ventilation breath has entered intothe lungs, then a confirmation may be provided along with an indicationof which source (ETCO2, TTI, or both) has provided the confirmation instep 1460. If a breath is not detected, then the medical device 202determines whether the timer has expired in step 1462. If the timer hasnot expired, then the medical device 202 returns to step 1458 to attemptto detect a physiological signal that confirms whether the positivepressure breath or a spontaneous patient breath has entered into thelungs. If such a confirmation has not been detected 1458 and the timerhas expired in step 1462, then an alert is displayed in step 1464. Thealert may provide a suggestion to check whether the intubation tube isproperly placed.

While not illustrated in this figure, in one embodiment, the timer willautomatically reset upon detection and/or confirmation of the breath(oxygen) being provided to the lungs of the patient. Additionally oralternatively, the medical device may include an input to enable theuser to manually reset the timer.

FIGS. 16C and 16D are flow charts illustrating examples of the stepsperformed during the post intubation verification in accordance with anembodiment. Specifically, as breaths are detected, the medical device202 monitors and analyzes the breaths over time to determine if thepatient is improving or worsening. That is, the medical device 202determines, based on analyzed breaths, whether the patient haspotentially begun spontaneous respiration (e.g., unassisted breathing)or if patient is no longer receiving oxygen (e.g., tube has becomedislodged, is leaking, etc.).

Referring to FIG. 16C, in the first step, 1470 the medical device 202detects a predefined number of breaths (e.g., between 3-10 detectedbreaths). By way of example, the breaths may be detected via acousticsensors, capnography sensors, or impedance sensors (e.g., ETCO2,acoustic signals, or TTI). In one example, the number of predefinedbreaths may be pre-programmed into the medical device 202 or userconfigured upon initialization of the medical device. In general, thenumber of breaths needs to be large enough for the medical device 202 tomake accurate calculations based on measured ETCO2 and/or TTI values,while also filtering out noise and outlying values. At the same time,the number of detected breaths may be relatively minimal to reduce theamount of lag until useful information is generated. In one example thenumber of breaths is 2. However, the number of measured ETCO2 and/or TTIvalues could be any number between 2 and 32 (or more).

In the next step 1472, the medical device 202 may identify outliervalues and/or trends and may generate an alert of the outlier or trendto indicate deterioration of the patient in step 1474. Thisidentification of outlier values and/or trends are additional specificexamples of predetermined criterion that may be satisfied to verify thata detected breath has entered into the lungs. This may be accomplishedby, for example, comparing measured ETCO2 values with other detectedbreaths and identifying deviations and or trends of widely increasingtrends. Illustrated by way of example, if the number of predefinedbreaths to be measured is 6, and values (measured mm Hg) of: 26, 27, 10,30, 31, and 28 were measured via capnography sensor; then, the medicaldevice 202 may be able to identify that the 3^(rd) value is an outlier.That outlier may provide an indication that the tube was dislodgedmomentarily or perhaps a section of tube was accidentally disconnected.Consequently, after the 3^(rd) breath is detected, the medical device202 may provide an alert, as indicated in step 1474, to check the tubeor patient. Likewise, if the remaining detected breaths return to normallevels, the medical device 202 may simply generate an event marker(e.g., code marker) for later review, in one example.

Similarly, as another example, if the detected breaths have ETCO2 values(mm Hg): 28, 28, 20, 18, 15, and 12, then the medical device 202 devicemay also generate an alert to check on the patient based on thedeteriorating ETCO2 values. In still another example, if the detectedbreaths have ETCO2 values (mm Hg): 20, 22, 28, 30, 35, and 40, then themedical device can provide an alert to check the patient as the trend ispositive and the ETCO2 value may be indicative of a different patientcondition. For instance, a substantial increase in ETCO2 (e.g., over 50%upward trend) could indicate the return of spontaneous circulation or asignificant change in the patient's condition. Or, such substantialchanges may be an indication that the intubation tube has fallen intoone of the lungs, when it is desirable for the distal end of the tube tobe positioned in the trachea so that ventilation breaths may be able toreach both lungs, rather than only one.

In step 1476, the medical device 202, when the ET tube is placed, maycalculate an average ETCO2 value (e.g., in mm Hg) based on the values ofthe detected predefined numbers of breaths (i.e., an initial baseline).This initial baseline provides a reference for future comparisons, forexample, of measured ETCO2 values (or other physiological values such asTTI and/or acoustic). As discussed herein, there are several methods todetermine a baseline. Likewise, there are several different times duringthe intubation procedure in which a baseline may be determined. In oneexample (discussed above, yet not illustrated in the figures), a priorbaseline may be determined prior to tube placement. This prior baselinewould represent the condition of the patient prior to any intubationattempts. Thus, any changes in the condition of the patient (i.e.,improvements or worsening) are compared against the patient's conditionprior to any treatment.

As disclosed in greater detail below, another example for determiningbaseline is to determine an initial baseline immediately after initialplacement of the ET tube. The benefit is that this initial baselinedetermination can represent both an indication of the condition of thepatient as well as a confirmation of the tube placement. For example, ifno ETCO2 values are measured, then the tube has not been properlyplaced. Likewise, if several ETCO2 values are identified and an initialbaseline is determined after tube placement, then the values areindicative of both a verification of a successful tube placement (i.e.,from the detected breaths) as well as an indication of the patient'scondition (e.g., 35-45 mm Hg is a typical value for a healthy patient,thus values lower than that provide an indication that the patient isstruggling to breath).

Additionally, another example of a baseline, which also disclosed indetail below, it to determine a dynamic baseline. This dynamic baselinemay be based, for example, on continually updated ETCO2 values (or otherphysiological values, such as TTI and/or acoustic) measured after thetube placement. This dynamic baseline may operate similar to a movingaverage. As newer ETCO2 values, for example, are detected by the medicaldevice, the newer values are included in the dynamic baselinedetermination simultaneously, older values decay or age out of thebaseline determination. One benefit of this type of baseline is that itprovides insight into the condition of the patient for a period of timesspanning multiple detected physiological values.

Returning to FIG. 16C, Next, the medical device 202 may set a dynamicbaseline equal to the initial baseline in step 1478. The dynamicbaseline is described in further detail below with respect to step 1492.The dynamic baseline may change as more breaths are detected, whereasthe initial baseline remains constant. Then, the medical device 202continues to detect breaths and measuring ETCO2 values in step 1480. Inthe next step 1482, the medical device 202 calculates an average ETCO2based on “X” numbers of consecutive breaths. This average of consecutivebreaths helps to reduce false alarms due to (e.g.) of noise and/oroutlier data. In general, “X” may be a relatively small number (e.g.,2-5 breaths), yet sufficient so that a pattern of breaths may bedetected (to eliminate noise/outliers).

The medical device 202 may then determine if the averaged ETCO2 value isgreater than, for example, 50% of the initial baseline and/or dynamicbaseline in step 1484. The initial baseline and/or dynamic baseline areadditional specific examples of predefined criterion of physiologicalmeasurement(s) that may be satisfied to verify that a ventilation breathhas reached the lungs. If the measured ETCO2 value is greater than, forexample, 50% of the initial baseline and/or dynamic baseline, then themedical device 202 generates an alert such as “CO2 Change, CheckPatient” in step 1486, for example, to check for spontaneous respiration(e.g., unassisted breathing) or other conditions of the patient. Thepurpose of checking the averaged ETCO2 against both the dynamic baselineand initial baseline is to enable the medical device to track thegeneral trend of the patient, as well as to enable to the medical deviceto be able to compare the current condition of the patient to theiroriginal condition (when first measured). For example, a patient thathas values that are slowly increasing or decreasing may never trigger analert (e.g., steps 1486, 1490), but overall the patient's condition, ascompared to their original condition, may be changing. While a thresholdpercentage change of 50% is provided in this example, it can beappreciated that other threshold percentage changes may be employed.

If the averaged ETCO2 value is not greater than 50% (or another suitablethreshold percentage) of the initial baseline and/or dynamic baseline,then the medical device 202 determines if the averaged ETCO2 value isless than 50% (or another suitable threshold percentage) of the initialbaseline and/or dynamic baseline in step 1488. In this case, if theaveraged ETCO2 value is less than 50% of the initial baseline and/ordynamic baseline, then the medical device 202 generates an alert such as“Low CO2, Check Airway” in step 1490. For instance, a substantial dropin ETCO2 (e.g., greater than 50% drop) could indicate dislodgment of theendotracheal tube. If the averaged ETCO2 value is not less than 50% ofthe initial baseline and/or dynamic baseline, then the medical device202 removes the oldest value (or possibly several values) from theaverage calculation and recalculates the average with the most recentvalue (or possibly several values) to update the dynamic baseline instep 1492. This dynamic baseline creates a “moving average”, which helpsto track trends in the ETCO2 values.

FIG. 16D is similar to FIG. 16C, except that the instead of using ETCO2values to measure breathing, the medical device 202 uses fortransthoracic impedance (TTI) values. A benefit of using TTI is that TTIis not a metabolic measure, but rather a measure of air having entered,or not entered, the lungs. Accordingly, TTI provides a measure that mayprovide more sensitivity to mechanical changes independent of thepatient's metabolic condition. As such, TTI may identify smallervariations, which be indicative of problems, which might otherwise goundetected with other means. While FIGS. 16C and 16D are described asbeing separate embodiments, the medical device could be implemented inconjunction.

Returning to FIG. 16D, in the first step, 1471 the medical device 202detects a predefined number of breaths (e.g., between 3-10 detectedbreaths). As before, the number of predefined breaths may bepre-programmed into the medical device 202. In the next step 1473, themedical device 202 may identify outlier values and/or trends. Similar tostep 1472 above, the identification of trends are examples ofpredetermined criterion. Then, generates an alert if the outlier ortrend indicates deterioration of the patient in step 1475. This may beaccomplished by, for example, comparing each measured TTI of each ofother the detected values breaths and identifying deviations and ortrends of widely increasing trends (similar to the methods describedwith respect to FIG. 16C).

In step 1477, the medical device 202 may calculate an average TTI value(e.g., in mm Hg) based on the values of the detected predefined numbersof breaths. This calculated average may provide an initial baseline thatprovides a point for future comparison of detected and measured TTIvalues. Next, the medical device 202 may set a dynamic baselineinitially equal to the initial baseline in step 1479. The dynamicbaseline may change as more breaths are detected, whereas the initialbaseline remains constant. Then, the medical device 202 continues todetect breaths and measuring TTI values in step 1481. In the next step1483, the medical device 202 calculates an average TTI based on “X”numbers of consecutive breaths. This average of consecutive breathshelps to reduce false alarms due to (e.g.) of noise and/or outlier data.

The medical device 202 then determines if the averaged TTI value isgreater than, for example, 50% of the initial baseline and/or dynamicbaseline in step 1484. If the measured TTI value is greater than, forexample, 50% of the initial baseline and/or dynamic baseline, then themedical device 202 generates an alert such as, “Check Airway” in step1487 as it may be possible that the tube has entered one of the lobes inthe lung. As discussed previously, it is desirable for the tube toremain in the trachea so that both lungs may receive air fromventilation breaths. As before, the purpose of checking the averaged TTIto both the dynamic baseline and initial baseline is to enable themedical device to track the general trend of the patient, as well as toenable to the medical device to be able to compare the current conditionof the patient to their original condition. For example, a patient thathas values that are slowly increasing or decreasing may never trigger analert (e.g., steps 1487, 1491).

If the averaged TTI value is not greater than 50% (or anotherappropriate percentage threshold) of the initial baseline and/or dynamicbaselines, then the medical device 202 determines if the averaged TTIvalue is less than 50% (or another appropriate percentage threshold) ofthe initial baseline and/or dynamic baseline in step 1489. If theaveraged TTI value is less than 50% of the initial baseline and/ordynamic baseline, then the medical device 202 may generate an alert suchas “Check tube” as the tube may have become dislodged in step 1491. Ifthe averaged TTI value is not less than 50% of the initial and/ordynamic baselines, then the medical device 202 removes the oldest value(or possibly several values) from the average calculation andrecalculates the average with the most recent value (or possibly severalvalues) to update the dynamic baseline in step 1493. This dynamicbaseline creates a “moving average,” which helps to track trends in theETCO2 values.

FIG. 16E is an exemplary user interface (dashboard) displayed on themedical device and/or portable computing device during thepost-intubation airway monitoring for verifying that the tube remainsproperly placed, and illustrates usage of an airflow sensor 127 indetecting and confirming that a positive pressure breath (e.g., oxygenventilation) has been appropriately given to the patient or that thepatient is spontaneously breathing.

As illustrated in the figure, the screen 1502 includes a verificationmode dashboard 1545, which may be presented along with the intubationassist dashboard as indicated in box 1540. Additionally, a statusindicator 1546 provides the current status (e.g., monitoring). The timerappears in box 1541, an indication of the type of flow sensor isprovided in box 1542, and confirmation box 1544 provides an indicationthat a delivery of a positive pressure breath (e.g., oxygen ventilation)has been given or that the patient is making spontaneous breathingefforts. In the illustrated example, the box 1544 is shaded. However, inone embodiment, the display may change a color (e.g., green) to indicatea breath has been detected. Alternatively, upon expiration of a timer,it may turn red to indicate a failure to detect the breath.

FIG. 16F is an exemplary user interface (dashboard) displayed on themedical device and/or portable computing device during thepost-intubation tube monitoring and illustrates the detection of lunginflation due to a change in impedance from electrodes 125 a, 125 b,correlated with the detected breath from the airflow sensor, indicatingthat the breath has reached the patient's lungs. As illustrated, upondetection that a breath has reached the lungs, a notification in thestatus indicator 1546 indicates that a breath was confirmed and alsoprovides an indication in box 1548 (e.g., turning green) as to whichphysiological sensor detected the breath. As before, the box may changea color (e.g., green) to indicate a breath has been detected.Alternatively, upon expiration of a timer, it may turn red to indicate afailure to detect the breath.

FIG. 16G is an exemplary user interface (dashboard) displayed on themedical device and/or portable computing device during thepost-intubation airway monitoring step and illustrates the detectionthat the breath has reached the patient's lungs from the capnographysensor 218, in detecting a CO2 waveform. Here, the CO2 waveform iscorrelated with the detected breath from the airflow sensor. Asillustrated, upon detection of a sufficient amount of CO2 a notificationin the status indicator 1546 indicates that a breath was confirmed andalso provides an indication in box 1550 (e.g., turning green) as towhich physiological sensor detected the breath.

FIG. 16H is an exemplary user interface (dashboard) displayed on themedical device and/or portable computing device during thepost-intubation tube monitoring step and illustrates the detection thatthe breath has properly reached the patient's lungs from the capnographysensor 218 (in detecting a CO2 waveform) and electrodes 125 a, 125 b (indetecting a change in transthoracic impedance). As illustrated, uponsuch confirmation from both capnography and impedance, a notification inthe status indicator 1546 indicates that a breath was confirmed and alsoprovides an indication in boxes 1448 and 1550 (e.g., turning green) thatboth physiological sensors detected the breath.

FIG. 16I is an exemplary user interface (dashboard) displayed on themedical device and/or portable computing device during thepost-intubation tube monitoring and illustrates the failure to detectthat the positive pressure breath has reached the patient's lungs, i.e.,the intubation tube is misplaced, and the alert indicating a failed tubeplacement. Alternatively, the medical device may only display alertswhen failure is detected to prevent a cluttering of the screen or one ormore alerts every time the BVM is used and/or a corresponding breath isdetected. For example, an alert may be displayed when a parametermismatch (e.g., change in TTI and/or ETCO2 past a threshold amount) isdetected, indicating that the intubation tube should be checked.Typically, these would be user configurable settings so that each user,rescuer, or team, could change the setting to their own liking.

As described previously, the failure of a capnography sensor 218 orelectrodes to detect a proper breath may be due to a number of reasonssuch as endotracheal tube 129 of FIG. 1B becoming dislodged from thesubject's trachea or the subject may have stopped breathing.Alternatively, a failure to detect a proper breath may be caused by abreak or leak in the breathing circuit (e.g., between the BVM and thecapnography sensor and/or the ET tube), or a break/leak between theairway sensor and the capnography sensor). Additionally, it may providean indication that the tube may have been placed down the esophagus(e.g., the pathway leading to the stomach). While the above embodimentdescribes usage of a flow sensor to detect the presence of airflow inthe patient airway in the context of post-intubation monitoring, it canbe appreciated that the flow sensor may also be used in the context ofinitial intubation assist and confirmation that the tube has beenproperly placed. For example, as discussed above, the air flow sensormay be used to detect that a positive pressure breath has initially beengiven. Then a timer may be initiated to confirm from one or morephysiological sensors (e.g., capnography, TTI, acoustic sensor) that thepositive pressure breath has entered the patient's lungs. Then, one ormore instructions for the rescuer to auscultate multiple sites (e.g.,left lung, right lung, abdomen, left axillary, right axillary) toconfirm whether the intubation tube has been properly placed may begiven. The rescuer may then be required to input into the medical deviceor portable computing device a positive or negative result ofauscultation in order to complete the intubation procedure.

As also discussed herein, it can be appreciated that the air flow sensormay be used in combination with an oxygen sensor to detect the presenceof oxygen in the patient's airway. This way, it can be confirmed that apositive pressure breath is not only applied to the patient, but thatthe positive pressure breath includes a desired amount/concentration ofoxygen.

Additionally or alternatively, the medical device may identify whetherit is likely that the patient is in cardiac arrest, for example, basedon the ECG waveform, or whether chest compressions are being applied tothe patient based on signals acquired from a motion sensor (e.g.,accelerometer) located on the sternum. It may be beneficial to identifywhich state the patient is in because the TTI and CO2 signal willtypically look markedly different depending on their state. If thepatient is in one of the states where the sensors are unable to reliablydetect/identify signals (e.g., TTI during CPR chest compressions), thenan alert may be displayed indicating that the CO2 or TTI signals may beunreliable, or simply might not use or display results from CO2 or TTI.For example, if chest compressions are being applied to the patient, asdetected by the motion sensor of a chest compression sensor located onthe sternum of the patient, then artifacts from the compressions mayshow up in the CO2 or TTI waveforms. Without proper signal artifactremoval, such waveforms may be less reliable for purposes of confirmingproper intubation tube placement. Accordingly, for certain embodiments,intubation confirmation procedures discussed herein may apply to caseswhere the patient is not undergoing chest compressions.

FIG. 17 is a flow chart illustrating typical steps performed after theverification of the endotracheal tube placement in accordance withembodiments of the present disclosure. In general, the post verificationmonitoring is related to ensuring that the successful tube placement isperforming as expected and that the patient is, and remains, in stablecondition. While the illustrated embodiment shows a series of sequentialsteps, in practice, the determinations made by the medical device may beoperating virtually simultaneously.

In the first step 1702, the medical device displays patient data. In thenext step 1704, the medical device 202 determines whether NIBP is belowa threshold (e.g., a systolic value less than 120 and/or a diastolicvalue less than 80) to monitor for hypotension, which often results fromintubation. Alternatively, the medical device monitors the trending NIBPto determine the “direction” the NIBP is heading. The NIBP threshold ischecked for hypotension, which is common due to diminished venous returnduring the RSI procedure. If the NIBP is below a preset threshold then,the medical device may provide an alert for the rescuer to takeintervening steps to increase blood pressure (e.g., providingmedication). The medical device 202 further determines whether theintubation parameters (e.g., ETCO2, O2, oxygen saturation, flowrate/volume) and measured sounds fall within acceptable limits in step1706. In various embodiments, the various physiologic data and airwaygas measurements may be closely monitored while the ET tube is in place,and the desired ranges for each of the parameters may be preconfiguredfor monitoring mode. If patient's intubation parameters (e.g., ETCO2,SpO2, flow rate/volume, vital signs) fall outside of the desired range(e.g., greater than 50 mmHg, below 88%, and 400 mL, respectively), thenthe medical device may provide an alarm and/or notification for therescuer to determine next steps.

If the ETCO2, O2, flow rate/volume and measured sounds are beingproperly displayed, then the medical device 22 determines if the chestmovements and either misting of tube or via increased humidity of theexhaled gas upon ventilation are present in step 1708 due to the distaltip of the tube being in proximity to the lungs. In one example, mistingof the tube may be detected via an optical window incorporated into theflow sensor. An LED is positioned to the side of the window and a lightsensor is positioned outside the window. The optical window when mistedwith the humidity from the exhalation will be bright from the lightscattered due to the condensation on the interior of the window.Alternatively, increased humidity in the exhaled gas may be measured viaa humidity sensor, such as the Honeywell HIH-4000-002, contained in theflow sensor. If the chest movements, misting, and/or increased humidityof the tube upon ventilation are present, then the medical device 202determines whether NFC transceivers on the flow sensor and ET tube areoperating in step 1710. If the NFC transceivers on the flow sensor andET tube are operating and the proximity between the transceivers isconfirmed, then the medical device 202 determines if the sensor testpassed 1712. This “sensor test” ensures that the various sensors of themedical device are operational and are providing relevant data.

If all of these conditional steps are completed successfully, then themedical device continues monitoring the patient, but also is able tomove to the next step in the procedure in step 1714. However, if any ofthe steps fail, then the medical device may activate an alarm anddisplays a warning message to the user. Typically, the medical devicedisplays a fault specific message indicating which step failed.

FIG. 18 is a flow chart illustrating typical steps performed during thepost-case debriefing in accordance with various embodiments.

In a typical implementation, the data from the post case debrief istransmitted to a central facility 224 or a personal computing device 225(e.g., a tablet, laptop, or smartphone). Alternatively, the informationcould be stored in the memory of the medical device 202 and thentransferred to a memory device (e.g., a USB memory stick) to transferthe information to the central facility. In still yet anotherembodiment, the information can simply be displayed on the display ofthe medical device. Additionally, the medical device 202 may present thepost case information and transmit the information to a central facility224.

In the first step 1802, the medical device may provide a history of thepatient vitals (e.g., intubation parameters), specifically noting thesignificant physiologic and airway gas parameters experienced by thepatient during the procedure. Next, in step 1804, the medical device 202may provide a flow history of relevant information (e.g., ETCO2waveforms, flow patterns, flow rate, volume, pressure,inspiratory/expiratory flow, peak inspiratory pressure) for the patientduring the tube placement procedure. The medical device 202 may alsoprovide any patient history information that was collected in step 1806.Next, in step 1808, the medical device 202 may provide timeline ofevents, which may also include the duration of each event, e.g.,preoxygenation, patient positioning, tube placement, tube verification,and medication administration, during the procedure along withnon-patient data related to the rescuers, deviceperformance/identification and environmental conditions.

In step 1810, the medical device 202 lists code markers employed duringthe procedure. The medical device 202 provides an alarm history (e.g.,leakage, dislodged tube, number of intubation attempts, etc.). In thelast step 1814, this information is transmitted to the central facility.

The features described can be implemented in digital electroniccircuitry, or in computer hardware, firmware, software, or incombinations of them. The apparatus can be implemented in a computerprogram product tangibly embodied in an information carrier, e.g., in amachine-readable storage device for execution by a programmableprocessor; and method steps can be performed by a programmable processorexecuting a program of instructions to perform functions of thedescribed implementations by operating on input data and generatingoutput. The described features can be implemented advantageously in oneor more computer programs that are executable on a programmable systemincluding at least one programmable processor coupled to receive dataand instructions from, and to transmit data and instructions to, a datastorage system, at least one input device, and at least one outputdevice.

A computer program is a set of instructions that can be used, directlyor indirectly, in a computer to perform some activity or bring aboutsome result. A computer program can be written in any form ofprogramming language, including compiled or interpreted languages, andit can be deployed in any form, including as a stand-alone program or asa module, component, subroutine, or other unit suitable for use in acomputing environment. Storage devices suitable for tangibly embodyingcomputer program instructions and data include all forms of non-volatilememory, including by way of example semiconductor memory devices, suchas EPROM, EEPROM, and flash memory devices, magnetic disks such asinternal hard disks and removable disks, magneto-optical disks, andCD-ROM and DVD-ROM disks.

The computing devices described herein may include, or be operativelycoupled to communicate with, one or more mass storage devices forstoring data files; such devices include magnetic disks, such asinternal hard disks and removable disks; magneto-optical disks; andoptical disks.

The terms “machine-readable medium,” “computer-readable medium,” and“processor-readable medium” as used herein, refer to any medium thatparticipates in providing data that causes a machine to operate in aspecific fashion. Using a computer system, various processor-readablemedia (e.g., a computer program product) might be involved in providinginstructions/code to processor(s) for execution and/or might be used tostore and/or carry such instructions/code (e.g., as signals).

In many implementations, a processor-readable medium is a physicaland/or tangible storage medium. Such a medium may take many forms,including but not limited to, non-volatile media and volatile media.Non-volatile media include, for example, optical and/or magnetic disks.Volatile media include, without limitation, dynamic memory.

Common forms of physical and/or tangible processor-readable mediainclude, for example, a floppy disk, a flexible disk, hard disk,magnetic tape, or any other magnetic medium, a CD-ROM, any other opticalmedium, punch cards, paper tape, any other physical medium with patternsof holes, a RAM, a PROM, EPROM, a FLASH-EPROM, any other memory chip orcartridge, a carrier wave as described hereinafter, or any other mediumfrom which a computer can read instructions and/or code.

Various forms of processor-readable media may be involved in carryingone or more sequences of one or more instructions to one or moreprocessors for execution. Merely by way of example, the instructions mayinitially be carried on a flash device, a device including persistentmemory, and/or a magnetic disk and/or optical disc of a remote computer.A remote computer might load the instructions into its dynamic memoryand send the instructions as signals over a transmission medium to bereceived and/or executed by a computer system.

The computing devices described herein may be part of a computer systemthat includes a back-end component, such as a data server, or thatincludes a middleware component, such as an application server or anInternet server, or that includes a front-end component, such as aclient computer having a graphical user interface or an Internetbrowser, or any combination of them. The components of the system can beconnected by any form or medium of digital data communication such as acommunication network. Examples of communication networks include alocal area network (“LAN”), a wide area network (“WAN”), peer-to-peernetworks (having ad-hoc or static members), grid computinginfrastructures, and the Internet. The computer system can includeclients and servers. A client and server are generally remote from eachother and typically interact through a network, such as the describedone. The relationship of client and server arises by virtue of computerprograms running on the respective computers and having a client-serverrelationship to each other.

Substantial variations may be made in accordance with specificrequirements. For example, customized hardware might also be used,and/or particular elements might be implemented in hardware, software(including portable software, such as applets, etc.), or both. Further,connection to other computing devices such as network input/outputdevices may be employed.

Information and signals may be represented using any of a variety ofdifferent technologies and techniques. For example, data, instructions,commands, information, signals, and symbols that may be referencedthroughout the above description may be represented by voltages,currents, electromagnetic waves, magnetic fields or particles, opticalfields or particles, or any combination thereof.

The methods, systems, and devices discussed above are examples. Variousalternative configurations may omit, substitute, or add variousprocedures or components as appropriate. Configurations may be describedas a process which is depicted as a flow diagram or block diagram.Although each may describe the operations as a sequential process, manyof the operations can be performed in parallel or concurrently. Inaddition, the order of the operations may be rearranged. A process mayhave additional stages not included in the figure. Specific details aregiven in the description to provide a thorough understanding of exampleconfigurations (including implementations). However, configurations maybe practiced without these specific details. For example, well-knowncircuits, processes, algorithms, structures, and techniques have beenshown without unnecessary detail in order to avoid obscuring theconfigurations. This description provides example configurations only,and does not limit the scope, applicability, or configurations of theclaims. Rather, the preceding description of the configurations willprovide those skilled in the art with an enabling description forimplementing described techniques. Various changes may be made in thefunction and arrangement of elements without departing from the scope ofthe disclosure.

Also, configurations may be described as a process which is depicted asa flow diagram or block diagram. Although each may describe theoperations as a sequential process, many of the operations can beperformed in parallel or concurrently. In addition, the order of theoperations may be rearranged. A process may have additional stages orfunctions not included in the figure. Furthermore, examples of themethods may be implemented by hardware, software, firmware, middleware,microcode, hardware description languages, or any combination thereof.When implemented in software, firmware, middleware, or microcode, theprogram code or code segments to perform the tasks may be stored in anon-transitory processor-readable medium such as a storage medium.Processors may perform the described tasks.

Components, functional or otherwise, shown in the figures and/ordiscussed herein as being connected or communicating with each other arecommunicatively coupled. That is, they may be directly or indirectlyconnected to enable communication between them.

As used herein, including in the claims, “and” as used in a list ofitems prefaced by “at least one of” indicates a disjunctive list suchthat, for example, a list of “at least one of A, B, and C” means A or Bor C or AB or AC or BC or ABC (e.g., A and B and C), or combinationswith more than one feature (e.g., AA, AAB, ABBC, etc.). As used herein,including in the claims, unless otherwise stated, a statement that afunction or operation is “based on” an item or condition means that thefunction or operation is based on the stated item or condition and maybe based on one or more items and/or conditions in addition to thestated item or condition.

Having described several example configurations, various modifications,alternative constructions, and equivalents may be used without departingfrom the disclosure. For example, the above elements may be componentsof a larger system, wherein other rules may take precedence over orotherwise modify aspects of the present disclosure. Also, a number ofoperations may be undertaken before, during, or after the above elementsare considered. Also, technology evolves and, thus, many of the elementsare examples and do not bound the scope of the disclosure or claims.Accordingly, the above description does not bound the scope of theclaims.

Other embodiments are within the scope of the present disclosure. Forexample, due to the nature of software, functions described above can beimplemented using software, hardware, firmware, hardwiring, orcombinations of any of these. Features implementing functions may alsobe physically located at various locations, including being distributedsuch that portions of functions are implemented at different physicallocations.

What is claimed is:
 1. A medical system for assisting a rescuer with anintubation procedure for a patient, the system comprising: one or moreairflow sensors configured to obtain data indicative of airflow in thepatient's airway; one or more physiological sensors configured to obtainphysiological information regarding airflow in the patient's lungs; apatient monitoring device communicatively coupled to the one or moreairflow sensors and the one or more physiological sensors, the patientmonitoring device comprising: a user interface comprising a display; andat least one processor and memory configured to: receive the dataindicative of the airflow in the patient's airway, determine thepresence of airflow in the patient's airway based on the received data,receive the physiological information regarding the airflow in thepatient's lungs, determine a physiological baseline regarding airflow inthe patient's lungs after placement of the ET tube, determine whetherthe ET tube remains properly placed based on a deviation from thephysiological baseline, and present to the display of the user interfacean output of the determination of whether the ET tube remains properlyplaced.
 2. The medical system of claim 1, wherein the physiologicalbaseline is an initial baseline determined upon initial placement of theET tube.
 3. The medical system of claim 2, wherein the initial baselinecomprises an average of a plurality of physiological values receivedupon initial placement of the ET tube.
 4. The medical system of claim 3,wherein the deviation from the physiological baseline comprises apercentage difference between a current physiological value and theinitial baseline.
 5. The medical system of claim 1, wherein thephysiological baseline is a dynamic baseline determined from updatedphysiological values obtained after initial tube placement.
 6. Themedical system of claim 5, wherein the dynamic baseline comprises amoving average of a plurality of physiological values received afterplacement of the ET tube.
 7. The medical system of claim 5, wherein theone or more physiological sensors includes at least one of a capnographysensor, acoustic sensor, and an impedance sensor.
 8. The medical systemof claim 1, wherein the one or more airflow sensors comprises at leastone of: an oxygen sensor for measuring a concentration of oxygen in thepatient's airway, a flow sensor for measuring gas flow rate in thepatient's airway, and a capnography sensor for measuring a concentrationof CO2 in the patient's airway.
 9. The medical system of claim 1,wherein the one or more physiological sensors comprises at least one of:a capnography sensor for obtaining ETCO2 information from the patient,an acoustic sensor for obtaining acoustic information from the patient,and impedance sensors for obtaining a transthoracic impedance of thepatient.
 10. The medical system of claim 9, wherein the one or morephysiological sensors comprises the capnography sensor and thephysiological baseline regarding the airflow in the patient's lungscomprises at least one ETCO2 value.
 11. The medical system of claim 10,wherein the at least one ETCO2 value comprises an initial baselinedetermined upon initial placement of the ET tube.
 12. The medical systemof claim 11, wherein the initial baseline is determined as an average ofa plurality of ETCO2 values upon initial placement of the ET tube. 13.The medical system of claim 12, wherein the deviation from thephysiological baseline comprises a percentage difference between atleast one current ETCO2 value and the initial baseline.
 14. The medicalsystem of claim 10, wherein the at least one ETCO2 value comprises adynamic baseline with continually updated ETCO2 values.
 15. The medicalsystem of claim 14, wherein the dynamic baseline comprises a movingaverage of a plurality of ETCO2 values received after placement of theET tube.
 16. The medical system of claim 9, wherein the one or morephysiological sensors comprises the transthoracic impedance sensor andthe physiological baseline regarding the airflow in the patient's lungscomprises at least one transthoracic impedance value.
 17. The medicalsystem of claim 16, wherein the at least one transthoracic impedancevalue comprises an initial baseline determined upon initial placement ofthe ET tube.
 18. The medical system of claim 17, wherein the initialbaseline comprises an average of a plurality of initial transthoracicimpedance values received upon initial placement of the ET tube.
 19. Themedical system of claim 18, wherein the deviation from the physiologicalbaseline comprises a percentage difference between a currenttransthoracic impedance value and the initial baseline.
 20. The medicalsystem of claim 16, wherein the at least one transthoracic impedancevalue comprises a dynamic baseline with continually updatedtransthoracic impedance values.
 21. The medical system of claim 20,wherein the dynamic baseline comprises a moving average of a pluralityof transthoracic impedance values received after placement of the ETtube.
 22. The medical system of claim 9, wherein the one or morephysiological sensors comprises the acoustic sensor and thephysiological baseline regarding the airflow in the patient's lungscomprises at least one spectral pattern.
 23. The medical system of claim22, wherein the at least one spectral pattern comprises an initialbaseline determined upon initial placement of the ET tube.
 24. Themedical system of claim 23, wherein the initial baseline comprises anaverage of a plurality of initial spectral components received uponinitial placement of the ET tube.
 25. The medical system of claim 24,wherein the deviation from the physiological baseline comprises apercentage difference between a current spectral component and theinitial baseline.
 26. The medical system of claim 22, wherein the atleast one spectral pattern comprises a dynamic baseline with continuallyupdated spectral pattern.
 27. The medical system of claim 26, whereinthe dynamic baseline comprises a moving average of a plurality ofspectral components received after placement of the ET tube.
 28. Themedical system of claim 1, wherein the patient monitoring devicecomprises a defibrillator.
 29. The medical system of claim 28, whereinthe patient monitoring device comprises an automated externaldefibrillator or a professional style defibrillator.
 30. The medicalsystem of claim 1, wherein the user interface is configured to displayfeedback including at least one of instructions for a rescuer andphysiological information.
 31. The medical system of claim 30, whereinthe visual feedback includes at least one of: oxygen saturation, endtidal CO2 (ETCO2), ECG signals from the patient, acoustic information, atransthoracic impedance, blood pressure, body temperature, heart rate,and respiration rate.
 32. The medical system of claim 31, wherein thedisplay is a touchscreen display configured to receive input from therescuer.
 33. The medical system of claim 1, wherein the patientmonitoring device includes one or more inputs for receiving informationfrom the rescuer.
 34. The medical system of claim 33, wherein the inputsinclude at least one of: softkeys, buttons, knobs, touchscreen inputs,and switches.
 35. The medical system of claim 1, further comprising oneor more portable computing devices communicatively coupled to thepatient monitoring device to transmit and receive patient informationfrom the patient monitoring device.
 36. The medical system of claim 35,wherein the one or more portable computing devices includes at least oneof a tablet computer, smartphone, and laptop.
 37. The medical system ofclaim 35, wherein the portable computing device includes a touchscreendisplay for receiving patient information from the rescuer, the patientinformation including at least one of: a height, a weight, and a genderof the patient.
 38. The medical system of claim 35, wherein the portablecomputing device connects to one or more central facilities to obtainadditional patient information about the patient.
 39. The medical systemof claim 35, wherein the determination of whether the ET tube remainsproperly placed is displayed on at least one of the display of thepatient monitoring device and the portable computing device.
 40. Themedical system of claim 1, wherein the at least one processor isconfigured to initiate a timer based on the determined presence ofairflow in the patient's airway.
 41. The medical system of claim 40,wherein the at least one processor is configured to determine whetherthe ET tube remains properly placed prior to expiration of the timer.42. The medical system of claim 41, wherein the at least one processoris configured to present the output of the determination of whether theET tube remains properly placed prior to the expiration of the timer.43. The medical system of claim 40, wherein the timer is a predefinedvalue between 5 and 15 seconds.
 44. The medical system of claim 40,wherein the timer is a user-defined value.
 45. The medical system ofclaim 1, wherein the determination of whether the ET tube remainsproperly placed is based on a correlation between the receivedphysiological information and the determined presence of airflow in thepatient's airway.
 46. The medical system of claim 45, wherein thecorrelation comprises a confirmation that a positive pressure breathgiven to the patient has reached the patient's lungs.
 47. The medicalsystem of claim 46, wherein the positive pressure breath given to thepatient results in the determined presence of airflow in the patient'sairway.
 48. The medical system of claim 1, wherein the at least oneprocessor and memory is configured to determine a prior baseline beforeplacement of the ET tube is initiated, and determine whether the ET tubeis properly placed based on a deviation from the prior baseline.
 49. Themedical system of claim 48, further comprising one or more impedancesensors for obtaining a transthoracic impedance of the patient, whereinthe prior baseline is based on the transthoracic impedance of thepatient.